| Methods |
Randomised double‐blind placebo‐controlled trial using fixed plasma level |
| Participants |
Outpatients aged 6‐12 years
15 female, 35 male
26 active treatment, 24 control
10 withdrawals |
| Interventions |
Nortriptyline. Dose calculated to obtain steady state plasma levels of 60‐100 ng/mL |
| Outcomes |
Depression items from the K‐SADS
Clinical Global Assessment Scale
Number of withdrawals
Side effect rating 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) |
Unclear risk |
Study 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 was used |
| 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 |
Different raters who had established inter‐rater reliability were used throughout the study |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Primary analysis was based on all cases randomised |
| Selective reporting (reporting bias) |
Unclear risk |
‐ |
| Other bias |
Unclear risk |
Current and previous treatments were not stated |
