[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 1
Included criteria: Subjects selected for the study consisted of male and female patients diagnosed as panic disorder by a psychiatrist based on DSM IV criteria. The subjects were recruited from among the patients attending the USM Hospital psychotherapy clinic. They were on a waiting list.They were divided at random into three groups,i.e.(1) the Fluvoxamine onlyg roup (FVX) group, (2) a group that were treated with both Fluvoxamine and cognitive behaviour therapy (FVX+CBT) and (3) a group that received only Cognitive Behaviour Therapy (CBT). The other inclusion criterias include; age between 18 to 50, ability to communicate well, cooperation to carry ou tsessions in a group for one hour per week.
Excluded criteria: The exclusion criterias include having other disorders besides panic, egophobias, hypochondriasis, other neuroses. All patients were required to give informed consent to enter the study. They were dropped from the study if they requested to be included in either group.
Intervention Characteristics
Intervention 1
Intervention 2
Kontrol 1
Grad af angst, HAM-A, mean, SD
Sponsorship source: No information
Country: Malaysia
Setting: Outpatient clinic
Authors name: M Z Azhar
Institution: Psychotherapy Clinic, Hospital Universiti Sains Malaysia
Address: Psychotherapy Clinic, Hospital Universiti Sains Malaysia,Kubang Kerian,16150 Kota Bahru, Kelantan
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 1
Included criteria: DSM-III-R criteria for panic disorder as a main diagnosis and had a minimum of 3 attacks in the 3-week run-in period.
Excluded criteria: Pregnant women, and patients with severe somatic deseases were excluded. Patients who used antidepressants, neuroleptics or benzodiazepines could only be included if they were willing and able to stop taking these drugs before the placebo run-in period.
Intervention Characteristics
Intervention 1
Kontrol 1
Grad af angst, HAM-A
Funktion, Sheeran Disability Scale
Grad af undgåelse, Mark Sheran phobia Scale, subscale agoraphobia
Bedring (free of panic attacts in the last three weeks of the intervention)
Frafald, alle årsager
Frafald, adverse events
Sponsorship source: Sponsered by a grant from SmithKline Beecham Pharmaceuticals
Country: The Netherlands
Setting: Outpatient clinics
Comments:
Authors name: Abraham Bakker
Institution: Department of Psychiatry and the institute for research in extramural medicine, Vrije University Amsterdam
Email: bramb@pca-znw.nl
Address: Valeriusplein 9, 1075 BG Amsterdam
Study design: Randomized controlled trial
Study grouping: Parallel group
Intervention 2
Kontrol 1
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 1
Kontrol 2
Included criteria: All patients passing diagnostic screeing for a principal diagnosis of PD withor without mild agoraphobia (N = 497) were entered in the pretreatment phase. Pretreatment included drug washout for patients taking anxiolytic or antidepressant medication. Patients were permitted up to 10 doses of benzodiazepine (0.5mg of alprazolam-equivalent) in the 2 weeks before the first treatment visit andup to 20 doses during baseline and acutetreatment combined. Diagnosis was confirmed using the Anxiety Disorders Interview Schedule-Revised (ADIS-R). Mild agoraphobia was operationally defined as a score less than or equal to 18 on the ADIS-R avoidance scale. Inaddition, inclusion required at least 1 fullor limited panic attack in the 2 weeks before the first treatment visit.
Excluded criteria: Exclusion criteria were psychotic, bipolar, or significant medical illnesses,suicidality, significant substance abuse,contraindications to either treatment,prior nonresponse to similar treatments, and concurrent competing treatment or pending disability claims. Mordetails are available on request from thauthors. Patients with comorbid unipolar depression were not exclude unless suicidal.
Intervention Characteristics
Intervention 1
Intervention 2
Kontrol 1
Kontrol 2
Grad af angst, Panic Disorder Severity Scale
Bedring, CGI-I responce rate, Score of 1 or 2
Alvorlige bivirkninger, SAE, antal personer
Ikke alvorlige bivirkninger, AE, antal personer
Sponsorship source: This work was supported by National Institute of Mental Health grant MH45964 (University of Pittsburgh School of Medicine); MH45965(Boston University); MH45966 (Yale University Schoolof Medicine); MH45963 and MH00416 (Senior Scientist Award) (Columbia University). Drs Barlow, Gorman, Shear, and Woods have received research sup-port from the National Institute of Mental Health. Imipramine and matching placebo were provided by Teva Pharmaceuticals USA.
Country: USA
Setting: Outpatient clinic
Authors name: David H. Barlow
Institution: Center for Anxiety and Related Disorders,Boston University
Address: David H. Barlow, PhD, Center for Anxiety and Related Disorders,Boston University, 648 Beacon St, Sixth Floor, Boston, MA 02215.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Patients with panic disorder between the age of 18 and 65 years. Structured clinical interview for DSM-III-R criteria for panic disorder. Patients meeting criteria for current or past DSM-III-R major depression were included. At least one panic attack in the final week of the observation period. An average weekly panic attack severity score of 25 based on the following formula: each panic attack was rated for severity on an 11-point scale (0, absent to 10, worst imaginable), and then the individual scores were added.
Excluded criteria: Patients who were pregnant, lactating, psychotic, suicidal, or demented, or who had significant medical illness, were ineligible. patients were not allowed to undergo additional psychotherapy or behavior therapy. Patients taking psychotropic medication were required to discontinue this medication for four weeks before randomization, or, in the case of tricyclic antidepressants 3 weeks before randomization.
Intervention Characteristics
Intervention 1
Kontrol 1
Grad af angst, Clinical anxiety scale
Funktion, Sheeran Disability Scale, subscale work
Bedring, Free of panic attacks at end of treatment
Frafald, alle årsager
Frafald, adverse events
Alvorlige bivirkninger, SAE, antal personer
Sponsorship source: This study was sponsered in part though a grant from Reid-Rowell Pharmaceuticals Inc, Atlanta, Ga.
Country: USA
Setting: Outpatient clinic
Authors name: Donald W Black
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 1
Included criteria: Inclusion criteria were: (1) a primary DSM-IV diagnosis of SAD;and (2) age between 18 and 65 years. To increase the comparability with other treatmentstudies of SAD and eliminate the possibility that improvements in SAD could be attributedto the antidepressant effects of phenelzine.
Excluded criteria: exclusion criteria were: (1) a comorbid anxietydisorder more clinically salient for the patient (2) lifetime history of schizophrenia, bipolardisorder, or mental disorder due to a general medical condition; (3) major depressive disorder or substance use disorder within the last 6 months; (4) prior failure of treatment with phenelzine or CBT defined as non response to 60 mg or more of phenelzine (or the equivalent dose of another MAOI) for at least 4 weeks or to 6 sessions of CBT for SAD; (5) concurrent psychiatric/psychological treatment; and, (6) pregnancy, lactation, or inability or unwillingness to use contraceptive measures for the duration of the study.
Intervention Characteristics
Intervention 1
Intervention 2
Kontrol 1
Grad af angst, LSAS, clinician rated
Grad af angst, LSAS (social fear subscale)
Funktion, Sheeran Disability Scale
Grad af undgåelse, social phobia scale
Bedring, CGI-I responce rate, Score of 1 or 2
Frafald, alle årsager
Sponsorship source: Supported in part by NIH grants DA023200 (Dr. Blanco), MH44119 (Dr. Heimberg) and MH57148 (Dr.Liebowitz), and the New York State Psychiatric Institute (Drs. Blanco, Schneier, Campeas and Liebowitz and Ms.Vermes). This work was also supported in part by GCRC grant RR00349 from the NCRR:NIH to Temple University
Country: USA
Setting: Outpatient clinics
Authors name: Carlos Blanco
Institution: Department of Psychiatry, New York State Psychiatric Institute, College of Physicians andSurgeons of Columbia University, New York, NY
Email: cb255@columbia.edu
Address: Carlos Blanco, M.D., Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, Box 69, New York,NY 10032, Telephone: 212-543-6533, Facsimile: 212-543-6515
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: a) DSM-III-R criteria for panic disorder with no, mild, or moderate agoraphobic avoidance. b) current episode duration at least 6 months. c) a least three panic attacks in the last three weeks. d) Consider panic their main problem. e) age 18 - 60 years. f) willing to accept random allocation.
Excluded criteria: g) no depressive disorder, sever enough to require immediate psychiatric treatment. h) no cognitive therapy, applied relaxation or imipramine in the current episode. i) no evidence of organic mental disorder, schizophrenia, alcohol or drug dependence, cardiovascular disease, asthma, epilepsy, pregnancy or intention to become pregnant.
Intervention Characteristics
Intervention 1
Kontrol 1
Grad af angst, HAM-A
Grad af undgåelse, Fear Questionnaire, social phobia subscale
Bedring, Free of panic attacks
Tilbagefald, relapse and required further treatment, percentages
Sponsorship source: Medical research council of the united kingdom
Country: England
Setting: Outpatient clinic
Authors name: David M Clark
Institution: Department of psychiatry, university of Oxford
Address: Department of psychiatry, university of Oxford, Warneford hospital, Oxford OX3 7JX
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: All the completers in thesample met DSM-IV criteria for PD (N = 31) or Panic Disorder with agoraphobia (N = 19)
Excluded criteria: The exclusion criteria were: 1) age less than 18, 2) comorbid psychiatric diagnosis and substance abuse (including benzodiazepines and alcohol), 3) psychological treatment in the past year, and 4) lack of ability to sign informed consent. The enrolled patients did not have any other Axis I diagnoses.
Intervention Characteristics
Intervention 1
Kontrol 1
Grad af angst, HAM-A
Bedring, Free of panic attacks, no panic attacks per week.
Frafald, alle årsager
Frafald, adverse events
Sponsorship source: The study was partially supported by a personal grant from the ministry of health, Israel.
Country: Israel
Setting: Outpatient clinic
Authors name: PINHAS N. DANNON
Institution: Chaim Sheba Medical Center, Psychiatry Ward Tel Hashomer and the Sackler School of Medicine, Tel Aviv University, Tel Aviv,Israel
Email: pinhasd@post.tau.ac.il
Address: Pinhas N Dannon, M.D., Rehovot Community Mental Health and Rehabilitation, Center. Remez Str80, 76449 Rehovot, Israel.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 1
Kontrol 2
Included criteria: Inclusion criteria were: (1)DSM-IV diagnosis of GSP; (2) age between 18 and 65 years; (3) fluency in English; and (4) provisionof written informed consent.
Excluded criteria: Exclusion criteria were: (1) a primary co-morbid anxiety disorder (defined by which disorder was the more debilitating and clinically salient); (2) lifetime history of schizophrenia, bipolar disorder, or organic brain syndrome; (3)major depression within the last 6 months; (4) substance abuse or dependence within the past year; (5) mental retardation or pervasive developmental disability; (6) unstable medical condition;(7) prior failure of response to fluoxetine at 60 mg/d for at least4 weeks or to 12 weekly sessions of CCBT for GSP; (8) concurrent psychiatric treatment or other psychoactive medications; (9) positive urine drug screen results; (10) inability to maintain 2 weeks’ psychotropic drug-free washout; and (11) pregnancy or lactation.
Intervention Characteristics
Intervention 1
Intervention 2
Kontrol 1
Grad af angst, Social phobia and anxiety inventory
Grad af undgåelse, Brief social phobia scale
Frafald, alle årsager
Frafald, adverse events
Alvorlige bivirkninger, SAE, antal personer
Sponsorship source: This study was supported by grant R10-MH49339-05A1 from the National Institute of MentalHealth, Bethesda, Md (Drs Davidson and Foa)
Country: USA
Setting: Outpatient clinic
Authors name: Jonathan R. T. Davidson
Institution: Department of Psychiatry andBehavioral Sciences, DukeUniversity Medical Center,Durham,
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: For study inclusion, prospective patients had to meet criteria for social phobia and had to be between 18 and 65 years old, fluent in English, willing to provide written informed consent, and able to participate responsibly in treatment.
Excluded criteria: Exclusions included schizophrenia, major depression, prominent risk of self-harm, organic mental disorder,history of bipolar I disorder, alcohol or substance abuse(within the past 6 months), a previous adequate trial of cognitive behavioral therapy ( over or equal to 6 sessions) or MAOI treatment (phenelzine sulfate over or equal to 45 mg/d, or the equivalent dosage of another MAOI for 4 weeks) for social phobia, or any serious medical condition that would increase the patient’s chances of being harmed by study participation.
Intervention Characteristics
Intervention 1
Kontrol 1
Grad af angst, LSAS (social fear subscale)
Grad af undgåelse, LSAS (avoidance subscale)
Bedring, Social Phobic Disorder severity (a score 1or 2 of 7)
Frafald, alle årsager
Frafald, adverse events
Alvorlige bivirkninger, SAE, antal personer
Sponsorship source: Supported by grants MH44 119 (Dr Heimberg) and MH40 121 (Dr Liebowitz) from the National Institute of Mental Health, Bethesda, Md, and grant PO5 MH30906 from theNew York State Psychiatric Institute Mental Health ClinicalResearch Center, New York. Parke-Davis Pharmaceuticals,Morris Plains, NJ, supplied Nardil and matching placebo.
Country: USA
Setting: Outpatient clinic
Authors name: Richard G. Heimberg,
Institution: Center for Stress and Anxiety Disorders, StateUniversity of New York at Albany
Email: e-mail: rheimber@nimbus.ocis.temple.edu
Address: Richard G. Heimberg, PhD,Adult Anxiety Clinic of Temple, Department of Psychology, Temple University, Weiss Hall, 1701 N 13th St, Philadelphia, PA 19122-6085
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Kontrol 1
Included criteria: Eligible were all adults aged over 60 years with a principal diagnosis of panic disorder (PD) or PD with agoraphobia (PDA) treatment in our out-patient clinic specialized in the yreatment of anxiety disorders. All patients were referred by their primary care physician.
Excluded criteria: Exclusion criteria were the presence of severe psychiatric disorders (e.g. psychotic disorder, bipolar disorder), a severe somatic condition that would hinder appropriate application of CBT (e.g. severe cardiovascular disease), a contraindication for paroxetine, current use of an antidepressant in an adequate dose, current and adequate psychological treatment, failure of paroxetine or CBT in the past,abuse of or dependency on alcohol or psychoactive substances, dementia and a score of 23 or less on the Mini-Mental State Examination. Co-morbidity with other anxiety disorders, depression or dysthymia was allowed as long as PD(A) was the principal diagnosis. Participants using benzodiazepines were asked to adhere to a fixed daily dose for the duration of the study (also see the Procedure and Treatment sections).
Intervention Characteristics
Intervention 1
Kontrol 1
Funktion, SCL-90
Grad af undgåelse, Mobility Inventory Avoidance Scale
Bedring, Free of panic attacks, numbers
Frafald, alle årsager
Frafald, adverse events
Sponsorship source: No information
Country: The Netherlands
Setting: Outpatient clinic
Authors name: Hendriks G-J
Institution: Forum GGz Nijmegen, Department for Anxiety Disorders ``Overwaal'', Nijmegen,
Email: ghendriks@overwaal.nl
Address: Gert-Jan Hendriks, Forum GGz Nijmegen, Department for Anxiety Disorders Overwaal, Pastoor vanLaakstraat 48, 6663 CB Lent, the Netherlands.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 2
Included criteria: To minimize placebo response and select patients with at least moderately severe PD, participants had to have a minimum ofsix full panic attacks in the 4-week period prior to the screen visit, and two full panic attacks a week in the 2-week lead-in period before the baseline visit. Co-morbid depression, generalized anxiety disorder, social phobia, somatization disorder and specificphobia were allowed as long as these conditions were secondary to and not clinically more prominent than the PD AG. To prevent the inclusion of severely depressed patients, subjects were eligible if their score on the 21-item Hamilton Depression Rating Scale was under 17 (Hamilton, 1960).
Excluded criteria: Patients were excluded if they had other Axis I psychiatric disorders; electroconvulsive therapy in the past 6 months; a history of psycho surgery; significant medical conditions; abnormal laboratory findings; a hypersensitivity to serotonergic agents; a history of non-response to sertraline; lactose intolerance; significant suicide risk; and use of any psychotropics within 14 days of the baseline visit (6 weeks for fluoxetine) or treatment with CBT in the past 12 months. Oxazepam was allowed during the study if needed, with a maximum daily dose of 15 mg and a weekly total dose of 60 mg. Women who werepregnant, lactating or not using reliable contraception were excluded.
Pretreatment:
Intervention Characteristics
Intervention 1
Intervention 2
Kontrol 2
Funktion, Sheehan Disability Scale, subscale work
Grad af undgåelse,Mobility Inventory Avoidance Scale
Frafald, alle årsager
Frafald, adverse events
Sponsorship source: The canadian Institutes of Health Research (POP-15247) and Pfizer Canada
Country: Canada
Setting: Outpatient clinic
Authors name: Koszycki
Institution: Faculty of education, university of Ottawa, ON, Canada
Email: dkoszyck@uottawa.ca
Address: Faculty of education, university of Ottawa, ON, Canada, 145 Jean-Jacques Lussier, Ottawa, Ontario, KIN 6N5, Canada
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 1
Included criteria: Inclusion criteria were as follows: age of 18–65 years, fulfillment of DSM-IV criteria for SAD, and symptoms present for at least 6 months.
Excluded criteria: Exclusion criteria were any form of physical disease, psychotic illness, acute suicidality, a primary diagnosis of major depressive disorder, diagnosis of body dysmorphic disorder, drug or alcohol dependence, and cluster A or cluster B personality disorders. Subjects not willing to accept random allocation were also excluded. We excluded patients who had been exposed to CT or to SSRIs previously in order to eliminate any bias of negative expectations to the treatment offered. Participants who were pregnant or were planning to become pregnant during the next 6 months were excluded due to the drug condition.
Pretreatment:
Intervention Characteristics
Intervention 1
Intervention 2
Kontrol 1
Grad af angst, Beck anxiety inventory, mean, SD
Bedring, recovered or improved at the Fear of negative evaluation questionnaire
Tilbagefald, deteoriated at the the Fear of negative evaluation questionnaire
Alvorlige bivirkninger, SAE, antal personer
Sponsorship source: No external sponsors were involved.
Country: Norway
Setting: Outpatient clinic
Authors name: Hans M. Nordahl
Institution: Departments of Psychology and Neuroscience, Norwegian University of Science and Technology, St. Olav’s University Hospital, Trondheim , Norway
Email: hans.nordahl @ svt.ntnu.no
Address: Department of Psychology University Outpatient Clinic, NTNU, Dragvoll NO–7491 Trondheim (Norway)
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 1
Kontrol 2
Included criteria: (a) Patients presented with panic disorder with or without agoraphobia that conformed to the Diagnostic and Statistical Manual of Mental Disorders (third edition, revised) criteria (DSM-III-R, American Psychiatric Association [APA], ; (b) patients scored a minimum of 15 on the Hamilton Anxiety Scale (HAM-A) at both entry (Day -7) and after one week wash-in (Day 0); (c) duration of the problem was greater than or equal to 3 months; (d) patients were aged between 18 and 70 years inclusive; (e) patients were willing and able to provide informed written consent to participation.
Excluded criteria: a) Patients were required to undergo a 4-week wash-out from concurrent psychotropic medication prior to entry, if required; (b) patients suffering from a major depressive disorder as defined by a score of 21 or greater on the Montgomery Asberg Depression Rating Scale (MADRS; Montgomery & Asberg. 1979) were excluded; (c) patients suffering from obsessive-compulsive disorder, paranoid personality disorder, schizophrenia, schizo-affective disorder, manic disorder, or other unspecified psychosis were excluded; (d) patients with severe concurrent somatic disease, particularly impairment of hepatic/renal function, or heart disease of significant clinical importance were excluded; (e) patients with evidence of epilepsy, organic brain disease, or other serious neurological deficit were excluded; (f) patients who were alcohol dependent or drug dependent or showed a risk of dependency were excluded; (g) patients considered a high suicide risk were excluded; (h) female patients who were pregnant, breast feeding, or who were not taking adequate contraceptive precautions were excluded; (i) patients who suffered from a physical disability that severely restricted mobility were excluded; (j) patients who had received psychological treatment for panic disorder and agoraphobia within the 6 months prior to entry were excluded; (k) patients who attended other therapists, whether lay or professional, were excluded.
Intervention Characteristics
Intervention 1
Intervention 2
Kontrol 1
Kontrol 2
Grad af angst, HAM-A
Bedring, Free of panic attacks
Frafald, alle årsager
Frafald, adverse events
Sponsorship source: This research was supported in part by Duphar Iaboratories Ltd. (Grant No. H114.928) who also supplied and packaged the Fluvoxamine and placebo medications.
Country: Scotland
Setting: Outpatient Clinic
Authors name: DONALD M. SHARP
Institution: Anxiety and Stress Research Cents, Department of Psychnlogy, University of Stirling, Scotland
Address: department of Psychology, University of Stirling, Stirling, FK9 4LA, Scotland
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Kontrol 1
Included criteria: Inclusion was restricted to patients between 18 and 65 years of age.
Excluded criteria: Patients who were pregnant, lactating, suicidal, psychotic, or severely depressed were ineligible to participate in the study. Further exclusion criteria comprised contraindications to either treatment or a concurrent competing treatment. Patients were not allowed to use psychotropic drugs except small doses of benzodiazepines (maximum the equivalent of 20 mg of oxazepamper day).
Intervention Characteristics
Intervention 1
Intervention 2
Kontrol 1
Grad af angst, HAM-A
Grad af angst, Panic Disorder Severity Scale
Grad af angst, Clinical anxiety scale
Grad af angst, LSAS, clinician rated
Grad af angst, LSAS (social fear subscale)
Grad af angts, Beck Anxiety Inventory
Grad af angst, Social phobia and anxiety inventory
Funktion, Sheeran Disability Scale
Funktion, Sheeran Disability Scale, subscale work
Grad af undgåelse, Mark Sheran phobia Scale, subscale agoraphobia
Grad af undgåelse, social phobia scale
Grad af undgåelse, Fear Questionnaire, social phobia subscale
Grad af undgåelse, Brief social phobia scale
Grad af undgåelse, Mobility Inventory Avoidance Scale
Grad af undgåelse, LSAS (avoidance subscale)
Bedring, Remitters % (free of panic attacts, minimal anxiety and minimal agoraphobia)
Bedring, responders at 3 of four at the following CGI-I, CGI-S, PGE-I or PGE-S.
Bedring, Free of panic attacks
Frafald, alle årsager
Frafald, adverse events
Sponsorship source: Grant number OG00-029 from the Dutch Health Insurance Board
Country: The Netherlands
Setting: Outpatient clinics
Comments:
Authors name: Franske J. van Apeldoorn
Institution: University Medical Center Groningen
Email: f.j.van.apeldoorn@psy.umcg.nl
Address: Franske J. van Apeldoorn, MSc, University Medical Center Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands
Wrong intervention
Wrong comparator
genoptryk af gammelt studie
Wrong study design
Duplicate
Wrong intervention
Wrong intervention
Wrong comparator
Wrong intervention
genoptryk af gammelt studie
Duplicate
Wrong comparator
Wrong comparator
Wrong intervention
Wrong intervention
Wrong intervention
Wrong patient population
Wrong intervention
Wrong intervention
Wrong patient population
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Judgement Comment: No information of how the allocation sequence was generated.
Judgement Comment: No information of how the allocation sequence was generated
Judgement Comment: No information of how the allocation sequence was generated
Quote: "Randomization was stratified by site and presence of Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition– defined current major depression and was blocked within stratum. To improve trial efficiency, 30 unequal numbers of patients were randomized to the treatments (6 CBT, 6 imipramine, 5 CBT+ imipramine, 25 CBT+placebo, and 2 pla-cebo per block of 24) based on expected pairwise comparison effect sizes."
Judgement Comment: No information of how the allocation sequence was generated. Persume computere generated due to stratification
Judgement Comment: Patients were randomly assigned. No informaiton of how the allocation sequence was generated
Judgement Comment: Quote: Patients were randomozed according to a table of pseudorandom numbers by the New York site data manager, who had no patient contact.
Judgement Comment: No information of how the allocation sequence was geenrated
Judgement Comment: No information of how the allocation sequence was generated
Quote: "Subjects were assigned to treatment by block randomization, which was generated by computer program at Duke University Medical Center, in groups of 10, with 2 subjects assigned to each of the 5 conditions."
Judgement Comment: Computer generated allocation sequence
Quote: "Pretreatment assessment included an independent assessor inter- view, self-report questionnaires, and a behavioral test. Groups of 5 to 7 patients, stratified by social phobia subtype, were then randomly assigned to 12 weekly sessions of 1 of the 4 treatments."
Judgement Comment: No information of how the allocation sequence was generated
Quote: " patients were randomly assigned to one of the three study conditions according to a 2: 2: 1 schedule. To this end, a sealed envelop was randomly selected from an initial total of 75 envelopes containing the treatment assignments, with 30 being labelled as "CBT", 30 as "paroxetine" and 15 as "waiting list".
Judgement Comment: Computer generated allocation sequence
Quote: "The participants were randomly assigned to 1 of 4 conditions. The randomization used gender and diagnosis of APD as stratification variables in blocks of 10 to ensure equal distribution."
Judgement Comment: Presume the allocation sequence was computed generated
Judgement Comment: No information of how the allocation sequence was generated.
Quote: "Patients were randomly allocated to treatment via a blind draw of a raffle ticket. Equal proportions of tickets for each treatment modality were present and the total number of tickets equaled the expected number of patients per site."
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: No information of allocation concealment.
Judgement Comment: No information of allocation concealment
Judgement Comment: No information of allocation concealment
Judgement Comment: No information of allocation concealment
No information on allocation concealment
Quote: "Patient allocation was concealed from all other research personnel at both sites prior to randomization and from independent evaluators providing the clinician-administered assessments throughout the study."
Judgement Comment: no information of allocation concealment
Judgement Comment: No information of allocation concealment
Quote: "The study coordinator at each site enrolled and allocated subjects to their treatment groups. This individual was blind to the sequence prior to assignment."
Judgement Comment: No information of allocation concealment
Judgement Comment: No information of allocation concealment.
Judgement Comment: Placebo and sertraline were provided as matching capsules and administered double-blind. Investigators at each site were provided with a sealed envelope that contained the identification of the study drug being administered to the patient. In a medical emergency, the investigator was authorized to break the code for that subject only
Quote: "The randomization lists were kept independently of the principle investigator, the psychiatrists, and the therapists. Blinding"
Judgement Comment: No information of allocation concealment.
Quote: "Randomization was stratified by site. Patients were randomly allocated to treatment via a blind draw of a raffle ticket. Equal proportions of tickets for each treatment modality were present and the total number of tickets equaled the expected number of patients per site."
Judgement Comment: No information of how the allocation sequence was generated
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: No information of blinding of participants and health care professionals. No use of placebo medication described. Blinding of CBT not feasible,
Judgement Comment: Patients were blinded to medication and placebo drug. Blinding of patients receiving CBT and health care providers of CBT not feasible.
Quote: "Patients assigned to the medication groups received dobble-blind paroxetine, clomipramine or placebo"
Judgement Comment: Patients were blinded to medication and placebo drug. Blinding of patients receiving CBT and health care providers of CBT not feasible.
Quote: "Patients assigned to the medication groups received dobble-blind paroxetine, clomipramine or placebo"
Quote: "The imipramine and placebo interventions were administered in a double-blind, fixed flexible-dose design, accord-ing to a manual developed for this study. Both the imipramine and placebo arms included a medical management com- ponent, specified in the manual."
Judgement Comment: Patients were blinded for Imipramine and placebo. Blinding of CBT not feasible.Low risk for PICO 2Unclear risk for PICO 1
Judgement Comment: Not possible to blind participants and personel Participants were blinded for Fluoxamine and placebo drug. Blinding of CBT not feasible
Judgement Comment: Participants and personel were blinded to placebo/phenelzine. Blinding to CBT not feasible.
Judgement Comment: No information of blinding of participants or health care providers, blinding of CBT not feasible
Judgement Comment: No inforrmation of blinding of participants and personel, blinding to CBT not feasible.
Judgement Comment: Participants were blinded to medication/placebo drug. Blinding to CBT not feasible.
Judgement Comment: Patients were blinded for medication/placebo drug. Blinding for CBT not feasible.
Judgement Comment: No information of blinding, blinding of CBT not feasible.
Judgement Comment: Sertraline and placebo double-blinded. Patients obviously aware of SCBT allocation but were instructed not to divulge assignmement to investigators. Paitents and personel were blinded for medication/placebo. Blinding for CBT not feasible.
Quote: "In the groups receiving pills, we applied triple masking, and the patient, the psychiatrists, and the principle investigator were blinded to which treatment (drug or placebo) was administered."
Quote: "Blinding was conducted for the treatment conditions using medication or placebo and achieved for the primary outcome measures by using independent evaluators who were blinded to the treatment assignment"
Judgement Comment: Patients and personel was blinded for medication/placebo. Blinding of CT not feasible
Judgement Comment: No inforamtion of blinding.Participants were blinding for medication/placebo, blinidng of CBT not feasible.PICO 1: Unclear riskPICO 2: Low risk No inforamtion of blinding.Participants were blinding for medication/placebo, blinidng of CBT not feasible.PICO 1: Unclear riskPICO 2: Low risk
Judgement Comment: No blinding of participants and health care providers, blinding not feasible for CBT.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Quote: "the following tests were done/measured by a research assistant who is blind to the patients' group. The scales are all self-reports and the research assistant only guides the subjects."
Judgement Comment: Likely outcome assessor is blinded (HAM-A).Research assistant were blinded but outcomes were stated as self-reported. these scales are normally clinician rated
Judgement Comment: No information of blinding of outcome assessors (HAM-A)Patients receiving medication or placebo were blinded regarding self-reported scores( PGE, Sheehan disability score and overall phobia score)Blinding of patients in the CBT-group not feasible Self-reported panic symptoms were recorded in panic diaries and ths scales MSPS, PGE and SDS were self-reported. Other assessors were "experienced residents in psyciatry" however, unclear how they were blinded.
Judgement Comment: No information of blinding of outcome assessors (HAM-A)Patients receiving medication or placebo were blinded regarding self-reported scores( PGE, Sheehan disability score and overall phobia score)Blinding of patients in the CBT-group not feasible Self-reported panic symptoms were recorded in panic diaries and ths scales MSPS, PGE and SDS were self-reported. Other assessors were "experienced residents in psyciatry" however, unclear how they were blinded.
Quote: "Evaluator assessments occurred at base-line and after acute, maintenance, and follow-up phases, and evaluators were blind to treatment assignment."
Judgement Comment: PDSS were clinician rated and outcome assessors were blinded.
Judgement Comment: The outcomes were clinician rated ( Clinical anxiety Scale) and self-rated ( sheehan disability scale)The participants in the CBT group were not blinded.The participants in the fluvoxamine group were blinded for medication/placebo.The outcome assessor in the CBT group was not blinded.One of the outcome assessors in the medication group was not blinded, unclear whether the other assessor was.
Judgement Comment: Clinician rated outcomes: LSAS, CGI were performed by blinded outcome assessors elf rated outcoems: Sheehan disability scaleand social phobia scale (patiente were blinded to medication, not to CBT)
Judgement Comment: Number of panic attacks were self-reported.HAM-A and FQ social phobia were clinician rated by blinded outcome assessors
Judgement Comment: HAM-A were measured by blinded outcome assessors. Number of panic attacks were self reported and participants were not blinded.
Quote: "Primary outcome assessments by the blinded independent evaluator (IE) were as follows: (1) CGI Improvement scale, a 7-point rating measured improvement wherein response is defined as hav- ing a CGI Improvement score of 1 (very much improvement) or 2 (much improvement), and the 7-point CGI Severity scale 12 and (2) the Brief Social Phobia Scale (BSPS), an 18-item scale com- prised of fear, avoidance, and physiological symptoms. 14 Inde- pendent evaluator ratings were conducted at baseline and at weeks 4, 8, and 14. Success of the blinding procedure was not evalu- ated."
Judgement Comment: All outcomes were clinician rated, outcome assessors were blinded
Quote: "The independent as- sessor (IA), unaware of treatment condition, completed the 7-point rating of change from the Social Phobic Disorders Severity and Change Form. This rating was used to categorize treatment response. Patients rated 1 or 2 (markedly or moderately improved) were classified as respond- ers and patients rated 3 or higher were classified as nonresponders. Other IA Measures. The IA also administered the Liebowitz Social Anxiety Scale (LSAS),"
Judgement Comment: Clinician rated outcomes rated by blinded assessor
Quote: "All assessments were administered by trained, independent psychologists who were blind to the study and treatments delivered."
Judgement Comment: outcomes were self-reported and participants were not blinded.
Judgement Comment: Double-blinded design. Patients obviously aware of SCBT allocation but were instructed not to divulge assignmement to investigators. Outcome assessments were made by investigators who were blind to allocation of the drug and who were not told whether the patient was assigned to SCBT. Patients were instructed not to divulge their SCBT assignment to the investigators.Outcomes of interests were clinician rated.
Quote: "The participants, independent diagnosticians, psychiatrists, and the principal investigator remained blinded to the paroxetine alone and pill placebo conditions. In addition, specific instructions were given to all participants to avoid disclosing information about their treatment to the evaluators."
Quote: "In the groups receiving pills, we applied triple masking, and the patient, the psychiatrists, and the principle investigator were blinded to which treat- ment (drug or placebo) was administered."
Quote: "Blinding was conducted for the treatment conditions using medication or placebo and achieved for the primary outcome measures by using independent evaluators who were blinded to the treatment assignment."
Quote: "Medication was supplied in 50-mg tablets, patients receiving placebo were given the equivalent number of tablets at each appointment, thus maintaining the double-blind status."
Judgement Comment: No information of blinding of outcome assessors.
Quote: "The Hamilton Anxiety Rat- ing Scale (HARS) 23 assesses general aspects of anxiety and was administered by trained research assistants."
Judgement Comment: No information of blinding of outcome assessors (HAM-A and remitter status)Quality of life scores and number of panic attacts were self-reported and participants were not blinded.PICO 1+2: High risk
Attrition bias due to amount, nature or handling of incomplete outcome data
Quote: "There were 66 patients with 22 patients in each group. However a total of 15 patients defaulted follow-up leaving 51 patients who completed 9 weeks of the study period with 17 patients in each group."
Judgement Comment: Moderate attrition (5/22) but balanced between groups however, no investigation of reasons for drop and no intention to treat analyses.
Judgement Comment: 4 (12.5%) dropped out in the paroxetine group, 3 (9.4 %) in the clomipramine group, 9 (25.7%) in the CBT group.8 dropped out in the CBT due to lact of patient compliance, 1 dropped out in the paroxetine and clomipramine group respectively, due to lack of patient compliance.Imbalance in dropouts both in numbers and reasons. Intention to treatanalyses were performed with last observation carried forward Similar low attrition between groups (<30%) with described reasons for dropout. ITT analysis.
Judgement Comment: 4 (12.5%) dropped out in the paroxetine group, 3 (9.4 %) in the clomipramine group, 9 (25.7%) in the CBT group.8 dropped out in the CBT due to lact of patient compliance, 1 dropped out in the paroxetine and clomipramine group respectively, due to lack of patient compliance.Imbalance in dropouts both in numbers and reasons. Intention to treat analyses were performed with last observation carried forward Similar low attrition between groups (<30%) with described reasons for dropout. ITT analysis.
Quote: "326 patients randomized, 312 are included in the analysis. Thirteen were excluded following uniform screening for loss of eligibility, and 1 was re- moved because of inadvertent unblinding. Proportions of excluded patients were not significantly different among treatment assignments."
Judgement Comment: 4 of 25 dropped out in the fluvoxamine group (16%) . 9 of 25 dropped out in the CBT group (36%). reasons for dropout stated.No intention to treat analyses
Judgement Comment: High number of dropouts in alle three groups, 23/45 (51%) in the pheneline group, 18/40 (45%) in the CBT group and 19/42 (45%) in the Pheneline+ CBT group. Reasons for dropout not stated. No intention to treat analyses, expect for the respons rate, where last observation caried forward was used Even when ITT was used there was an extensive drop out rate in all groups. (almost 50%) Nothing described about imputation methods but even IF they had used a imputation methods statistics cannot save data when 50% drops outs
Judgement Comment: No diagram of participant flow. 72 were randomised. 16 in each group completed 3 month. Hereafter 12 patients from the waiting list were randomised to the three intervention groups. resulting in 20 in each group at 6 month follow up. No intention to treat analysis. Dropouts and refuseres after randomisation were replaced and not included in the analyses.
Judgement Comment: Unbalance number of dropouts. 6/33 in the medication group(du to adverse events) 1/24 in the CBT gropu (trip abroad)No intention to treat analyses
Judgement Comment: Numbers and reasons for dropout stated. 18/57 dropped out in the medication group.12/60 dropped out in the CBT group.17/59 dropped out in the medication + CBT group.13/59 dropped out in the CBT+ placebo group. Intention to treatanalyses performed
Judgement Comment: dropouts were balanced in numbers, reasons for dropout not stated per groupIntention to treat analysis for treatment responce, but not for the other outcomes
Judgement Comment: 3/17 dropped out in the paroxetine group. 1/20 dropped out int he CBT group. Reasons stated. No intention to treat analyses
Judgement Comment: Moderate but balanced attrition with reasons reported. ITT analysis. About 25-30% dropped out in each group. Numbers and reasons for dropout are balanced across groupsIntention to treat analyses.
Quote: "All data were analyzed based on an intention-to-treat approach, and missing data were treated using last observation carried forward on the primary measure."
Judgement Comment: Numbers and reasons for dropout stated in all groups. Intention to treat analyses with last observation carried forward.
Judgement Comment: Numbers and reasons for dropout stated. A higher dropout rate in the CBT group.
Judgement Comment: 15/49 (31%) dropped out in the CBT+ SSRI group21/53 (40%) dropped out in the CBT group17/48 (35%) dropped out in the SSRI group Reasons for dropout stated. Missing outcome data are balanced in numbers and reasons. Reasons for dropouts reported. Non-significant dropout rates between groups.
Reporting bias due to selective outcome reporting
Judgement Comment: No protocol available. The study reports on all the outcomes stated in the methods section.
Judgement Comment: No protocol available, the study reports on all the outcome stated in the methods section No protocol however, alle outcomes reported as expected including both completers and ITT.
Judgement Comment: No protocol available, the study reports on all the outcome stated in the methods section No protocol however, alle outcomes reported as expected including both completers and ITT.
Judgement Comment: No reference to a protocol, but the protocol is available at ClinicalTrials.gov Identifier: NCT00004834. No outcomes stated in the protocol. The study reports on all the outcomes stated in the methods section. primary and seconday outcomes as expected, were reported as stated for both completer and ITT for all three time points.
Judgement Comment: No protocol available. The study reports on all the outcoems stated in the methods section
Judgement Comment: No protocol available. Reports on all the outcome stated in the methods section
Judgement Comment: No protocol available, the study reports on all the outcomes stated in the methods section
Judgement Comment: No protocol available, the study reports on all the outcoems stated in the methods section
Judgement Comment: No reference to a protocol. The study reports on all outcomes stated in the methods section
Judgement Comment: No reference to a protocol, the study reports on all the outcomes stated in the method ssection.
Judgement Comment: Trial registration: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC = 1144. Beck Depression Inventory (BDI) was stated in the protocol but not reported in the publication. No reporting of anxiety severity in the study.
Judgement Comment: No protocol available. The study reports on all the outcomes stated in the methods section
Quote: "The study protocol was approved by the Regional Committee for Medical and Health Research Ethics of Central Norway (No. REK-018-03), the Norwegian Medicines Agency (SN 04-01998) and the Norwegian Data Inspectorate (ClinicalTrials.gov identifier: NCT00184106)."
Judgement Comment: The protocol is available at clinicaltrials.gov. Only the primary outcome stated in the protocol and the outcome is reported in an other way than stated in the protocol. No secondary outcomes stated in the protocol, but the study repoerts on all the secondary outocmes stated in the method section. The study protocol and reported outcomes do not match. The study reports on outcomes that is not prespecified
Judgement Comment: The study reports only the main measures. stated that a variety of measures were colloected
Quote: "Trial Registration: Netherlands Trial Register (www.trialregister.nl) Identifier: ISRCTN8156869"
Judgement Comment: Reference to a protocol, the protocol not available. The study reports on all the outcome stated in the methods section. No reasons to suspect selective outcome reporting.
Bias due to problems not covered elsewhere in the table
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: Study supported by a grant from the industry and no statements about conflicts of interest.
Judgement Comment: Study supported by a grant from the industry and no statements about conflicts of interest.
Quote: "Funding/Support: This work was supported by National Institute of Mental Health grant MH45964 (University of Pittsburgh School of Medicine); MH45965 (Boston University); MH45966 (Yale University School of Medicine); MH45963 and MH00416 (Senior Scientist Award) (Columbia University). Drs Barlow, Gorman, Shear, and Woods have received research support from the National Institute of Mental Health. Imipramine and matching placebo were provided by Teva Pharmaceuticals USA."
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: Not clear if the medical company which gave a grant to the study took part in the analyses and the revision of the manuscript.
Quote: "Acknowledgments Financial Support Supported in part by NIH grants DA023200 (Dr. Blanco), MH44119 (Dr. Heimberg) and MH57148 (Dr. Liebowitz), and the New York State Psychiatric Institute (Drs. Blanco, Schneier, Campeas and Liebowitz and Ms. Vermes). This work was also supported in part by GCRC grant RR00349 from the NCRR:NIH to Temple University.
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study apperas to be free of other sources of bias. Note that due to an unexpected staff shortage, an additional group of 8 patients who had been randomized receive CBGT was not able to participate in the study.
Quote: "This study was supported by grant R10- MH49339-05A1 from the National Institute of Mental Health, Bethesda, Md (Drs Davidson and Foa). Additional Information: Medication and matching placebo were provided by Eli Lilly, Indianapolis, Ind, who have reviewed the manuscript. They were uninvolved in study design, data analysis, or manuscript preparation."
Judgement Comment: The study appears to be free of other sources of bias. Parke-Davis Pharmaceuticals,Morris Plains, NJ, supplied Nardil and matching placebo.
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: This work was supported by the Canadian Institutes of Health Research (POP-15247) and Pfizer Canada. We thank Dr V. Hadrava of Pfizer Canada for his generous support during the study.
Quote: "The study was financially supported by the Departments of Psychology and Neuroscience at the Norwegian University of Science and Tech- nology (NTNU), Trondheim. No external sponsors were involved."
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study appears to be free of other sources of bias
Quote: "The authors have no personal affiliations or financial relationships with any commercial interest to disclose relative to the article. Funding/support: Grant number OG00-029 from the Dutch Health Insurance Board"
Judgement Comment: The study appears to be free of other sources of bias