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. |
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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 |
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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. |
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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.