Butterfield 2001.
Methods | DESIGN
Description: random‐assignment, placebo‐controlled, parallel arm, flexible dose, double‐blind BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: Unclear RANDOMISATION Method: Unclear |
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Participants | SAMPLE
Description: 15 DSM‐IV PTSD, mean age: 43.2 years (26‐73), 14 women, 53.3% (8/15) MDD, most common comorbid diagnosis: GAD ‐ 64.3% (9/15), baseline severity on TOP‐8: olanzapine (19.3), placebo (21.8) SCREENING Primary diagnosis: SIP Comorbidity: MINI |
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Interventions | Description: olanzapine 5 mg/d ‐ 20mg/d (max. mean 14.1 mg/d) versys placebo (max. mean: 13.9mg/d) x 10 weeks | |
Outcomes | Primary outcomes: TOP‐8, SPRINT,
Secondary outcomes: IES, DTS, CGI‐I, SDS, BAS, AIMS Data estimation: ITT (General linear model) |
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Notes | INDUSTRY SUPPORT
Industry funded: Yes
Medication provided by industry: No
Any of the authors work for industry: No ADDITIONAL INFORMATION Drop‐out rates: 3/15 (20%) on olanzapine and 1/5 (20%) on placebo. Quality rating score: 24 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |