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. 2013 Jun 18;2013(6):CD002317. doi: 10.1002/14651858.CD002317.pub2

Keller 2001.

Methods Randomised double‐blind 3‐arm placebo‐controlled trial that also included the serotonin reuptake inhibitor drug, paroxetine
Participants Psychiatric outpatients aged 12‐18 years
 69 males and 113 females randomised to receive imipramine or placebo. A further 35 males and 58 males received paroxetine
Interventions Imipramine 200‐300 mg/day in divided doses
Outcomes Hamilton Rating Scale for Depression
 Schedule for Affective Disorders and Schizophrenia for Adolescents Lifetime version
 Clinical Global Impression scale
 Follow‐up interval 8 weeks
Notes Study quality score = 28
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was carried out using a computer‐generated table
Allocation concealment (selection bias) Low risk
Blinding (performance bias and detection bias) 
 of participants Low risk Visually identical capsules were used for all 3 arms of the study
Blinding (performance bias and detection bias) 
 of personnel Unclear risk No description was provided
Blinding (performance bias and detection bias) 
 of outcome assessors Low risk Assessors were blind to the subject allocation and used a standard assessment toll
Incomplete outcome data (attrition bias) 
 All outcomes Low risk A last observation carried forward dataset was analysed along with a completer dataset
Selective reporting (reporting bias) Unclear risk
Other bias Unclear risk Level of compliance was not stated