Harrison 1986.
Methods | Design: RCT Phases: continuation treatment (26.1 weeks) after response to phenelzine treatment Comparison groups: phenelzine vs placebo Funded by: probably internal funding by the authors' institution, no information given |
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Participants | Number of participants randomized (NRCT: number of participants included): 12 Criteria for relapse/recurrence: "Patients were considered to have relapsed and were withdrawn from the protocol if they scored 3 or more on the CGI for 2 consecutive weeks. Patients received a score of 3 on the CGI only if they had a clear recurrence of depressive symptoms." (p. 347) Age distribution in sample: unclear Sex distribution in sample (% women): 83.3 Diagnoses in sample: phenelzine: 20.0% dysthymia, 80.0% double depression; placebo: 58.0% dysthymia, 42.0% double depression Depression severity at continuation/maintenance baseline (mean): HAM‐D phenelzine: 1.8 (SD 1.3); placebo: 4.4 (SD 3.9) Age of onset: unclear Length current/last major episode in months: unclear |
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Interventions | Continuation treatment (26.1 weeks) Phenelzine (participants = 5) Name (class and type): phenelzine (MAOI) Planned dosage of drug: unclear Dosage of drug (mean): 51.0 (SD 7.4) mg/day Placebo (participants = 7) Name (class and type): tablet placebo Planned dosage of placebo: NR Dosage of placebo: NR Notes: the placebo group discontinued phenelzine treatment over 14 days by tapering the daily dose by 15 mg every 2–3 days according to a predetermined schedule. No information about concomitant treatments. |
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Outcomes | Relapse/recurrence HAM‐D mean Dropout any Dropout due to adverse event Experiencing any adverse event (no data available for the placebo group) Serious adverse events (no data available for the placebo group) |
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Notes | After relapse, participants were treated openly as clinically indicated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The double blind condition was maintained by providing individual daily medication packets in which the number of tablets was kept constant by substituting matching placebo." (pp. 346–7) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | No study protocol |
Other bias | Unclear risk | Insufficient treatment adherence: no information on treatment adherence. Allegiance bias/conflict of interest: no information about funding/possible conflict of interest. Attention bias: no indication for attention bias, all participants in the placebo group also saw the physician. |