Davidson 2001b.
Methods | DESIGN
Description: random‐assignment, placebo‐controlled, relapse prevention study for participants undergoing acute and continuation treatment in Brady 2000 and Davidson 2001a BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: Unclear RANDOMISATION Method: unclear |
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Participants | SAMPLE 96 DSM‐III‐R PTSD, mean age=43.4 years, SD=10.3, 30% male SCREENING Responders (CGI ≤ 2, ≥30% improvement on total severity score for CAPS) in last two sessions of 28 week continuation treatment with sertraline |
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Interventions | Sertraline 50‐200 mg/d (avg 137 mg/day) vs. placebo (avg 145 mg/day) x 28 weeks | |
Outcomes | Primary outcomes: Rates and times to event for 1) relapse, 2) relapse or discontinuation because of clinical deterioration (self‐
rated), and 3) acute exacerbation of PTSD.
Secondary outcomes: CAPS, HAM‐D, QLES Data estimation: Not applicable for primary outcomes (Kaplan Meier survival analysis) |
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Notes | INDUSTRY SUPPORT Industry funded: Yes (as reported in acute and continuation phase studies) Medication provided by industry: No (as reported in acute and continuation phase studies) Any of the authors work for industry: Yes |