Marshall 2001.
Methods | DESIGN
Description: random‐assignment, comparator and placebo‐controlled, parallel arm, fixed dose, double‐blind, 1 week placebo run‐in BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: Unclear RANDOMISATION Method: Unclear |
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Participants | SAMPLE
Description: 563 DSM‐IV PTSD, mean age: 41.8 years, 57% (315 /551) female, average duration of diagnosis: 15.7 years, approximately 45% (248/551) comorbid MDD, baseline severity on CAPS‐2:: paroxetine 20mg/d (75.3), paroxetine 40mg/d (74.3), and placebo ( 74.4) SCREENING Primary diagnosis: MINI, CAPS‐1, CAPS‐2 >= 50 Comorbidity: No information |
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Interventions | Description: paroxetine (25 mg/d) or paroxetine (50 mg/d) versus placebo x 12 weeks | |
Outcomes | Primary outcomes: CAPS‐2, CGI‐I
Secondary outcomes: DTS, TOP‐8, SDS, MADRS Data estimation: LOCF (1 post‐baseline assessment) |
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Notes | INDUSTRY SUPPORT
Industry funded: Yes
Medication provided by industry: No information
Any of the authors work for industry: Yes ADDITIONAL INFORMATION Drop‐out rates: 35% (66/188) on 20mg/d paroxetine, 40% (74/187) on 40mg/d paroxetine, and 36% (68/188) placebo Quality rating score: 26 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |