Baker 1995 a.
Methods | DESIGN
Description: random‐assignment, placebo‐controlled, parallel arm, flexible dose, double‐blind, single‐blind placebo run‐in BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: Unclear RANDOMISATION Method: Unclear |
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Participants | SAMPLE
Description: 146 DSM‐III‐R PTSD, average age: 44 years (23‐73), 81% male, mean duration of diagnosis: 12.8 years, MDD not present, 60% combat‐related SCREENING Primary diagnosis: symptoms at least 6 months, CAPS >= 45, MADRS <= 22 Comorbidity: MADRS |
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Interventions | Description: brofaromine up to 150 mg/d vs placebo x 12 weeks | |
Outcomes | Primary outcomes: CAPS
Secondary outcomes: IES, DTS, CGI NOTES: CGI (values not reported, CGI‐C obtained from Davidson et al, 1997), ITT (LOCF 1 post‐baseline assessment) values provided. |
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Notes | INDUSTRY SUPPORT
Industry funded: Not mentioned
Medication provided by industry: No
Any of the authors work for industry: Yes ADDITIONAL INFORMATION Drop‐out rates: total of 35 Quality rating score: 15 Single‐blind placebo run‐in excluded 28 placebo‐responders Obtained additional HAM‐D and CAPS‐2 summary statistics from Sudie Back |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |