| Methods |
Randomised double‐blind placebo‐controlled trial using fixed plasma level |
| Participants |
Depressed outpatients aged 12‐17 years
Gender unknown
12 active treatment, 19 placebo
4 withdrawals |
| Interventions |
Nortriptyline in a dose sufficient to maintain steady state plasma levels at 60‐100 ng/mL |
| Outcomes |
Children's Depression Rating Scale
Number of withdrawals
Side effect rating scale
Follow‐up interval 8 weeks |
| Notes |
Study abandoned at midpoint owing to very low likelihood of demonstrating statistically significant treatment effect
Study quality score = 25 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Study was described as random but no further description was provided |
| Allocation concealment (selection bias) |
Unclear risk |
No description was provided |
| Blinding (performance bias and detection bias)
of participants |
Low risk |
Visually identical capsules given at the same frequency were used |
| Blinding (performance bias and detection bias)
of personnel |
Unclear risk |
No description was provided |
| Blinding (performance bias and detection bias)
of outcome assessors |
High risk |
Not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Numbers and reasons for withdrawals were provided but analysis was not modified |
| Selective reporting (reporting bias) |
Unclear risk |
‐ |
| Other bias |
Unclear risk |
Concurrent and previous treatments were not stated |
