Davidson 2001a.
| Methods | DESIGN
Description: random‐assignment, placebo‐controlled, parallel arm, flexible dose, double‐blind, multicentre, 1 week single‐blind placebo run‐in BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: Unclear RANDOMISATION Method: computer generated |
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| Participants | SAMPLE
Description: 208 DSM‐III‐R PTSD, 5% war trauma, mean age: 37.1 (18‐69), 78% male, duration of diagnosis: 12.3 years, 40% (83/208) MDD, baseline severity on CAPS‐2: sertraline (73.9) placebo (73.5) SCREENING Primary diagnosis: CAPS‐1, CAPS‐2 >= 50, minimum 6 months duration Comorbidity: None |
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| Interventions | Description: sertraline 25 mg/d to between 50‐200 mg/d (avg: 146.3 mg/d) vs. placebo x 12 weeks | |
| Outcomes | Primary outcomes: CAPS‐2, IES, CGI‐S, CGI‐I
Secondary outcomes: DTS, HAM‐D, HAM‐A, PSQI Data estimation: LOCF (1 post‐baseline assessment) |
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| Notes | INDUSTRY SUPPORT
Industry funded: Yes
Medication provided by industry: No
Any of the authors work for industry: Yes ADDITIONAL INFORMATION Drop‐out rates: 30% on sertraline and 27% on placebo (not clear which sample was used as denominator) Quality rating score: 33 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |