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

Miller 2001.

Methods Design: RCT
Phases: acute (10–12 weeks), continuation (16 weeks), maintenance (104.4 weeks)
Comparison groups: desipramine vs placebo
Funded by: supported by grant R01‐MH37103 from the National Institute of Mental Health and from a fund established in the New York Community Trust by DeWitt‐Wallace.
Participants Number of participants randomized (NRCT: number of participants included): 27
Criteria for relapse/recurrence: "Recurrence was defined as HAM‐D scores > 12 and GAS scores < 60 on three successive ratings over a period of 4 weeks or at least one rating meeting these criteria and an urgent need for alternative treatment for recurrence of depressive symptoms." (p. 233)
Age distribution in sample (mean): desipramine: 34.4 (SD 9.6) years; placebo: 39.0 (SD 11.2) years
Sex distribution in sample (% women): desipramine: 43.0; placebo: 46.0
Diagnoses in sample: 100% dysthymia
Depression severity at continuation/maintenance baseline (mean): desipramine: 3.1 (SD 2.5); placebo: 3.9 (SD 5.2)
Age of onset (mean): desipramine: 14.5 (SD 10.4) years; placebo: 12.3 (SD 8.0) years
Length current/last major episode: unclear
Interventions Maintenance treatment (104.4 weeks)
Desipramine (participants = 14)
Name (class and type): desipramine (TCA)
Dosage of drug: unclear
Dosage of drug (mean): 223 (SD 90) mg/day
Placebo (participants = 13)
Name (class and type): placebo
Planned dosage of placebo: unclear
Dosage of placebo (mean): 240 (SD 60) mg/day (dummy dosage)
Notes: participants in the placebo arm were tapered down by 25% per week during the first month of maintenance treatment followed by receiving identical placebo tablets. 43% of participants from the desipramine group and 38% of participants from the placebo group were in stable long‐term psychotherapy during the study, a non‐significant difference.
Outcomes Relapse/recurrence
Notes Analysis of the dysthymic subgroup of Kocsis et al. 1996 and some additional participants with dysthymia.
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 Double‐blind maintenance phase
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Ratings were done by study clinicians who were blinded to treatment assignment, but may have guessed the maintenance treatment based on side effects, potentially biasing ratings of outcome." (p. 235)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data for the available outcome.
Selective reporting (reporting bias) High risk No study protocol available, only recurrence rates were reported, HAM‐D, GAS, and SASR was also measured.
Other bias Low risk Insufficient treatment adherence: serum level control.
Allegiance bias/conflict of interest: no indication for a conflict of interest.
Attention bias: same approach in both conditions (quote: "monthly 20–30 minute appointments to monitor clinical status and manage side effects. Therapists provided support and encouragement, and medication compliance was discussed throughout." (p. 232)

CBASP: Cognitive Behavioral Analysis System of Psychotherapy; CGI: Clinical Global Impression; CIGP‐CD: Cognitive‐Interpersonal Group Psychotherapy for Chronic Depression; CT: cognitive therapy; DSM‐III‐R: Diagnostic and Statistical Manual of Mental Disorders 3rd Edition – Revised; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders 4th Edition; GAS: Global Assessment Scale; HAM‐D: Hamilton Depression Rating Scale; HRSD: Hamilton Rating Scale for Depression (also known as HAM‐D); IPT: interpersonal psychotherapy; LOCF: last observation carried forward; MAOI: monoamine oxidase inhibitor; MDD: major depressive episode; NR: not reported; NRCT: non‐randomized controlled trial; Q‐LES‐Q: Quality of Life Enjoyment and Satisfaction Questionnaire; RCT: randomized controlled trial; SAS‐SR: Social Adjustment Scale – Self‐Report; SD: standard deviation; SF‐36: 36‐item Short‐Form Health Survey; SNDRI: selective noradrenaline‐dopamine reuptake inhibitor; SSRI: selective serotonin reuptake inhibitor; SWLS: Satisfaction With Life Scale; TCA: tricyclic antidepressant.