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. 2019 May 20;2019(5):CD012855. doi: 10.1002/14651858.CD012855.pub2

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
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Criteria for relapse/recurrence: "Patients were considered to have relapsed and were withdrawn from the protocol if they scored 3 or more on the CGI for 2 consecutive weeks.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
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.
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)
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.