| Methods |
Design: three group parallel trial
Purpose: examine the effect of imipramine on depression in patients not spontaneously seeking treatment |
| Participants |
Patients: out‐patients with clinical depression identified through a door to door survey in a rural community
Baseline comparability: yes (score on Hamilton's depressive rating scale) |
| Interventions |
Placebo: tablets without imipramine (lactose)
Untreated: no tablets (observational group)
Experimental: tablets with imipramine
(Co‐intervention: NS) |
| Outcomes |
Score on Hamilton's rating scale |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 18 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
