Kocsis 2003.
Methods | Design: NRCT Phases: acute (12 weeks), continuation (16 weeks), maintenance (52 weeks) Comparison groups: nefazodone vs CBASP vs combination Funded by: Bristol‐Myers Squibb |
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Participants | Number of participants randomized (NRCT: number of participants included): 329 Criteria for relapse/recurrence: "Two definitions of relapse were utilized. Any patient who scored higher than 15 on the HAM‐D was considered at risk for a relapse of MDD. In all such cases, an independent evaluator completed the DSM‐IV criteria checklist for MDD, and if the patient met DSM‐IV symptom criteria, the treating clinician was notified. A confirmatory visit was scheduled within 14 days and the HAM‐D and MDD criteria checklist assessment were repeated. Patients meeting MDD criteria were evaluated by an independent senior investigator to confirm relapse. In addition, an investigator could declare a relapse on de facto grounds in the case of an exacerbation of depressive symptomatology with marked incapacity and clinically significant suicidal ideation, including psychiatric hospitalizations resulting from such exacerbations. Patients not meeting relapse criteria but continuing to score higher than 15 on the HAM‐D were followed every other week until their outcome was clarified." (p. 77) Age distribution in sample (mean): nefazodone: 43.1 (SD 9.7) years; CBASP: 44.0 (SD 10.8) years; combination: 44.6 (SD 9.4) years Sex distribution in sample (% women): nefazodone: 58.7; CBASP: 66.3; combination: 67.8 Diagnoses in sample: nefazodone: 32.6% chronic major depressive disorder, 41.3% double depression, 26.1% recurrent depressive disorder with incomplete remission between episodes; CBASP: 33.7% chronic major depressive disorder, 46.1% double depression, 20.2% recurrent depressive disorder with incomplete remission between episodes; combination: 32.2% chronic major depressive disorder, 42.1% double depression, 26.6% recurrent depressive disorder with incomplete remission between episodes Depression severity at continuation/maintenance baseline: unclear Age of onset (mean): nefazodone: 26.3 (SD 13.1) years; CBASP: 28.1 (SD 13.5) years; combination: 27.0 (SD 12.9) years Length current/last major episode in months (mean): nefazodone: 92.4 (SD 114.0); CBASP: 105.6 (SD 144.0); combination: 99.6 (SD 120.0) |
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Interventions | Continuation treatment (16 weeks) Nefazodone (participants = 91) Name (class and type): nefazodone (SNDRI) Planned dosage of drug: 300–600 mg/day Dosage of drug (mean): 499 (SD 115) mg/day CBASP (participants = 88) Name (class and type): CBASP Planned number of sessions: 6 Number of sessions (mean): 6 (SD 1) Combination (participants = 150) Name (class and type): combination (SNDRI + CBASP) Planned number of sessions + dosage of drug: 6 sessions + 300–600 mg/day Number of sessions + dosage of drug (mean): 5.9 (SD 1.1) sessions + 479 (SD 108) mg/day Notes: "Pharmacotherapists were directed not to provide any psychotherapeutic interventions." (p. 76) |
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Outcomes | Relapse/recurrence Dropout any |
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Notes | Probably conflict of interest because of funding and connection of the authors to pharmaceutical industry. |