Kosten 1991.
Methods | DESIGN
Description: random‐assignment, comparator and placebo‐controlled, parallel arm, flexible dose, double‐blind, multi‐centre BLINDING Participants: Yes Assessors: No Administrators: Unclear ALLOCATION CONCEALMENT Method: No information RANDOMISATION Method: Unclear |
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Participants | SAMPLE
Description: 60 DSM‐III‐PTSD, all combat veterans, mean age: 39 years, all males, no subjects with comorbid major depression, baseline severity on IES: imipramine (36.5), phenelzine (30.6) and placebo (33) SCREENING Primary diagnosis: SCID Comorbidity: SADS |
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Interventions | Description: imipramine 50 mg/d ‐ 300 mg/d (avg max. dose: 225 mg/d) versus phenelzine 15 mg/d ‐ 75 mg/d (avg max. dose: 68 mg/d) versus placebo x 8 weeks | |
Outcomes | Primary outcomes: IES
Secondary outcomes: Combat Scale; CAS; HAM‐D; HAM‐A; RSD Data estimation: LOCF (completers of 3 or more weeks) |
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Notes | INDUSTRY SUPPORT
Industry funded: No
Medication provided by industry: Yes
Any of the authors work for industry: Yes ADDITIONAL INFORMATION Drop‐out rates: 52% (12/23) on impramine, 21% (4/19) on phenelzine and 12/18 (67%) on placebo Quality rating score: 26 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |