| Methods |
Design: two group parallel trial
Purpose: examine the effect of continuous placebo treatment on relapse of chronic mild depression |
| Participants |
Patients: out‐patients with chronic, mild depression having improved markedly after a 10 day placebo medication
Baseline comparability: yes |
| Interventions |
Placebo: continuous treatment with a tablet (content NS)
Untreated: discontinued treatment with tablet
(Co‐intervention: NS) |
| Outcomes |
Number of patients with relapse of depression |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Treatment provider was not blinded |
| 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? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 50 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
