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. 2020 Sep 3;2020(9):CD007667. doi: 10.1002/14651858.CD007667.pub3

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:
  • sertraline (oral, maximum 200 mg/day, once daily) (number randomised unclear)

  • imipramine (oral, maximum 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. The 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 (Hellerstein 2000)