Brady 2004.
Methods | DESIGN
Description: random‐assignment, placebo‐controlled, parallel arm, fixed dose, double‐blind, 4 day tapering of medication at end of trial, single blind 1 week placebo run‐in BLINDING Participants: unclear Assessors: unclear Administrators: unclear ALLOCATION CONCEALMENT Method: unclear RANDOMISATION Method: urn randomisation by gender, depressive disorder, trauma type, and age of index trauma |
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Participants | SAMPLE
Description: 94 DSM‐IV PTSD with concurrent alcoholism (LOCF sample), no war veterans, mean age: 36.7 years, 54% male, SCREENING Primary diagnosis: CAPS, SCID, CAPS >= 30% decrease after placebo run‐in grounds for exclusion Comorbidity: TLFB |
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Interventions | Description: sertraline (50 mg/d ‐ 150 mg/d) versus placebo (50 mg/d ‐ 150 mg/d) x 12 weeks | |
Outcomes | Outcomes: OCDS, CAPS, HAM‐D, SID, IES (not clear whether primary or secondary) Data estimation: LOCF (1 post‐baseline assessment) |
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Notes | INDUSTRY SUPPORT
Industry funded: unclear
Medication provided by industry: Yes
Any of the authors work for industry: No ADDITIONAL INFORMATION Drop‐out rates: information not provided, 3 patients excluded as responders during placebo run‐in Quality rating score: 22 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |