Davidson 1990.
Methods | DESIGN
Description: balanced randomization, placebo‐controlled, parallel arms, flexible dose, double‐blind, single centre BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: Unclear RANDOMISATION Method: Unclear |
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Participants | SAMPLE
Description: 46 DSM‐III PTSD, chronic, combat veterans, presumably all males, inpatients included, 20% (9/46) MDD, most common comorbid diagnosis: GAD (16), baseline severity on IES: amitriptyline (33.1) placebo (36.8) SCREENING Primary diagnosis: SI‐PTSD Comorbidity: None |
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Interventions | Description: amitriptyline (50‐300 mg/d) vs placebo x 8 weeks, ongoing supportive psychotherapy | |
Outcomes | Primary outcomes: CGI‐I , SI‐PTSD, CGI‐S
Secondary outcomes: HAM‐D, HAM‐A, IES, NI, EPI Data estimation: completer values |
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Notes | INDUSTRY SUPPORT
Industry funded: No
Medication provided by industry: No
Any of the authors work for industry: No ADDITIONAL INFORMATION Drop‐out rates: 8/25 (32%) on amitriptyline, 5/21 (24%) 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 |