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 |