Katz 1994.
Methods | Description: random‐assignment, placebo‐controlled, parallel arm, flexible dose, double‐blind, multi‐centre, 2 week single‐blind placebo run‐in BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: No information RANDOMISATION Method: Unclear |
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Participants | SAMPLE
Description: 64 DSM‐III‐R PTSD, 17% (8/45) combat‐related, median age: 39 (22‐62), 76% male, duration of diagnosis: 2.8 years, baseline severity on CAPS: brofaromine (80.6) and placebo (82.9) SCREENING Primary diagnosis: CAPS > 36, response of >= 20% decrease on CAPS during placebo run‐in Comorbidity: HAM‐D > 21 |
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Interventions | Description: brofaromine 50 mg/d ‐150 mg/d versus placebo x 14 weeks | |
Outcomes | Primary outcomes: CAPS
Secondary outcomes: CGI Data estimation: LOCF |
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Notes | INDUSTRY SUPPORT
Industry funded: Yes
Medication provided by industry: Unclear
Any of the authors work for industry: Yes ADDITIONAL INFORMATION Drop‐out rates: 30% (10/33) on brofaromine and 29% (9/31) on placebo Quality rating score: 24 CGI‐C values obtained from Davidson et al, 1997 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |