Hellerstein 2000.
Methods | Design: placebo‐controlled parallel trial |
Participants |
Participants: outpatients with early‐onset dysthymia Sex: 266 female, 144 male (data not extractable for any AsPD subgroup; see note 1) Age: mean 42.0 (SD = 9.0) years (data not extractable for any AsPD subgroup; see note 1) Unit of allocation: individual participant. Number randomised: 410 (sertraline = 134, imipramine = 136, control = 140; see note 1) Number completing: completion rates: sertraline = 84%, imipramine = 67%, placebo = 76% (data not extractable for any AsPD subgroup; see note 1) Setting: outpatient; multi‐centre (17 sites), North America Inclusion criteria: early‐onset dysthymia (DSM‐III‐R) of at least 5 years' duration; score of 12 or higher on 29‐item Hamilton Depression Rating Scale (SAD version) at end of 1‐week single‐blind placebo washout period Exclusion criteria: major depression; pregnancy or lactation; history of drug or alcohol dependency/misuse within preceding 6 months; serious risk of suicide; current primary diagnosis of panic disorder or generalised anxiety disorder; lifetime diagnosis of bipolar disorder, obsessive compulsive disorder, or any psychotic disorder; failure to respond in two or more prior antidepressant trials; previous adequate trial of imipramine or sertraline treatment Ethnicity: Caucasian (95%, n = 390) (data not extractable for any AsPD subgroup; see note 1) |
Interventions | Three conditions:
Duration of intervention: 10 weeks Duration of trial: 10 weeks Length of follow‐up: participants were not followed up beyond the end of the intervention period Dose adjustment: sertraline initially 50 mg/day and titrated after weeks 4, 6 and 7 to a maximum of 200 mg/day; imipramine initially 50 mg/day and titrated weekly to a maximum of 300 mg/day; all participants received 4 identical capsules containing either placebo, 50 mg sertraline, or 50 or 100 mg imipramine |
Outcomes |
Primary outcomes Social functioning: Social Adjustment Scale scores Secondary outcomes Leaving the study early: Other outcomes Changes in personality dimensions (Tridimensional Personality Questionnaire) |
Notes |
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