van der Kolk 2004.
Methods | DESIGN
Description: random‐assignment, placebo‐controlled, parallel arm, flexible‐dose, double‐blind, multi‐centre, 6 month follow‐up BLINDING Participants: Unclear Assessors: Yes Administrators: Unclear ALLOCATION CONCEALMENT Method: No information RANDOMISATION Method: Unclear |
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Participants | SAMPLE
Description: 59 DSM‐IV PTSD, mean age: 34.9 years (18‐65), 86% (51/59) female, average duration of diagnosis: 13.3 years, baseline severity on CAPS: fluoxetine (73.7) and placebo (70.3) SCREENING Primary diagnosis: Trauma incident >= 1 year ago, GAF < 40 Comorbidity: Not mentioned |
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Interventions | Description: fluoxetine 10 mg/d ‐ 60 mg/d versus Eye Movement Desensitization and Reprocessing (EMDR) versus placebo x 5 weeks | |
Outcomes | Primary outcomes: CAPS
Secondary outcomes: BDI Data estimation: LOCF |
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Notes | INDUSTRY SUPPORT
Industry funded: No
Medication provided by industry: Unclear
Any of the authors work for industry: No ADDITIONAL INFORMATION Drop‐out rates: 13% (4/30) on fluoxetine and 10% (3/29) on placebo Quality rating score: 28 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |