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. Author manuscript; available in PMC: 2014 Sep 11.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007667. doi: 10.1002/14651858.CD007667.pub2
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, n = 134; imipramine, n = 136; control, n = 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; multicentre (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, OCD, 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: sertraline/ imipramine/ placebo.
  • sertraline (oral, max 200 mg/day, once daily) (number randomised unclear).

  • imipramine (oral, max 300 mg/day, once daily) (number randomised unclear).

  • placebo (oral, matching capsules, once daily) (number randomised unclear).


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 1. study may have recruited a subgroup with AsPD as 48 participants had DSM-III-R cluster B personality disorder, although this is unclear. No data extractable on any AsPD subgroup. Awaiting clarification from investigators