Martenyi 2002b.
Methods | DESIGN
Description: random‐assignment, placebo‐controlled, relapse prevention component of Martenyi 2002b BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: unclear RANDOMISATION Method: unclear |
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Participants | 131 DSM‐IV PTSD, 81% male, avg age = 38.2 years, 47% trauma combat related. Patients required to present with 50% decrease after 12 weeks of acute treatment with fluoxetine on the TOP‐8 score, a CGI–S score <= 2, and failed diagnostic criteria for PTSD | |
Interventions | Fluoxetine max avg dose at endpoint: 53 mg/d vs placebo x 24 weeks. Responders to 12 weeks of acute treatment with placebo maintained on placebo. No discontinuation taper of fluoxetine from the acute to relapse prevention phase | |
Outcomes | Primary outcomes: Time to relapse on TOPS‐8 (>= 40% increase for 12 week acute baseline) and CGI‐S (>= 2 on CGI‐S from 12 week acute baseline) Secondary outcomes: CAPS‐2, CGI‐I, DTS, MADRS, HAM‐A, SCL‐90‐R | |
Notes | INDUSTRY SUPPORT Industry funded: Yes Medication provided by industry: Not mentioned Any of the authors work for industry: No |