[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Atomoxetine
Lisdexamfetamine
Included criteria: 1. An inadequate response to previous MPH treatment. This included, but was not limited to, one or more of the following:•The presence of some residual ADHD symptoms•Inadequate duration of action•Variable symptom control•If, based on the investigator’s judgement, the patient maybenefit clinically from an alternative to MPH
Excluded criteria: 1. Intolerable adverse events from previous MPH treatment2. Previous exposure to amfetamine or ATX3. Previous treatment with more than one MPH medication•This did not include patients who had received immediaterelease MPH for dose titration on a short-term basis (B4 weeks)provided that they experienced an adequate response4. Failure to respond to more than one previous course of MPHmedication•Failure to respond was defined as a worsening, no change orminimal improvement of symptoms5. Good control of ADHD symptoms with acceptable tolerabilityon current ADHD medication
Pretreatment: No apparent differences at baseline
Intervention Characteristics
Atomoxetine
Lisdexamfetamine
ADHD kernesymptomer, observatør/kliniker bedømt, SD
Alvorlige bivirkninger-totalt, n
Frafald pga. bivirkninger, n
Appetitforstyrrelser
Vægttab, n
Søvnforstyrrelser, n
Sponsorship source:
Country: Germany
Setting: NA
Comments: ClinicalTrials.gov NCT01106430.
Authors name: Ralf W. Dittmann
Institution: Paediatric Psychopharmacology, Department of Child andAdolescent Psychiatry and Psychotherapy
Email: ralf.dittmann@zi-mannheim.de
Address: Paediatric Psychopharmacology, Department of Child andAdolescent Psychiatry and Psychotherapy, Central Instituteof Mental Health, Medical Faculty Mannheim, Universityof Heidelberg, 68072 Mannheim, German
Wrong study design
Wrong study design
Wrong comparator
Wrong study design
Wrong study design
Wrong comparator
Wrong comparator
Adult population
Wrong study design
Wrong study design
Wrong comparator
Wrong comparator
Wrong study design
Wrong study design
Wrong comparator
Wrong study design
Dublet
Wrong comparator
Wrong study design
Wrong intervention
Wrong comparator
Wrong comparator
Wrong study design
Wrong study design
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong study design
Wrong comparator
Wrong comparator
Wrong comparator
Wrong study design
Wrong comparator
Wrong comparator
Wrong study design
Wrong study design
Wrong study design
Wrong comparator
Wrong patient population
Wrong comparator
Wrong study design
Wrong study design
Wrong comparator
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong comparator
Wrong comparator
Wrong comparator
Wrong comparator
Wrong intervention
Wrong comparator
Wrong comparator
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "a 4-week, stepwise, dose-optimization stage. <b>Randomization of patients was stratified by country, and an automated interactive response system was used to generate the ran- dom (concealed) allocation sequence and assign partici- pants to study treatments; patients, caregivers and investigators were blinded to the treatment allocation. All study drugs were over-encapsulated so they appeared identical.</b> The dose-optimization phase involved adjustment"
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Quote: "(concealed) allocation sequence and assign <b>partici- pants to study treatments; patients, caregivers and investigators were blinded to the treatment allocation.</b> All study drugs were over-encapsulated"
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: Patients, caregivers and invedstigators are blinded
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Participants and investigators are blinded
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: Dropuouts have been accounted for
Reporting bias due to selective outcome reporting
Judgement Comment: Not all the secondary outcomes are reported in the study, however they are reported at clinicaltrials.gov
Bias due to problems not covered elsewhere in the table
Judgement Comment: No other apparent sources of bias.