Zohar 2002.
Methods | DESIGN
Description: random‐assignment, placebo‐controlled, parallel arm, flexible dose, double‐blind, mutli‐centre, 1 week single blind placebo run‐in BLINDING Participants: Unclear Assessors: Unclear Administrators: Unclear ALLOCATION CONCEALMENT Method: No information RANDOMISATION Method: Unclear |
|
Participants | SAMPLE
Description: 51 PTSD, 76% (32/42) combat‐related trauma, mean age: 40 years, 88% (37/42) male, baseline severity on CAPS‐2: sertraline (91.2) and placebo (93.3) SCREENING Primary diagnosis: minimum 6 month PTSD, CAPS‐1, CGI‐S >=4, CAPS‐2 >=50 required after placebo run‐in Comorbidity: Unclear |
|
Interventions | Description: sertraline 50 mg/d ‐ 200 mg/d (120 mg/d) versus placebo (avg:147 mg/d) x 10 weeks | |
Outcomes | Primary outcomes: CAPS‐2, CGI‐I, CGI‐S
Secondary outcomes: MADRS Data estimation: LOCF (1 post‐baseline assessment) |
|
Notes | INDUSTRY SUPPORT
Industry funded: Yes
Medication provided by industry: Unclear
Any of the authors work for industry: Yes ADDITIONAL INFORMATION Drop‐out rates: 26% (6/23) on fluoxetine and 26% (5/19) on placebo Quality rating score: 30 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
Acronyms for scales: AIMS: Abnormal Involuntary Movement Scale; ASEX: Arizona Sexual Experience Scale; ASI: Addiction Severity Index; BAS: Barnes Akathisia Scale; BDHI: Buss‐Durkee Hostility Inventory; BDI: Beck Depression Inventory; CADSS: Clinician Administered Dissociative States Scale; CAPS‐2: Clinician Administered PTSD Scale ‐ part 2; CAS: Covi Anxiety Scale; CES: Combat Exposure Scale; CES‐D: Center for Epidemiologic Studies Depression Scale (self‐rated); CGI‐I: Clinical Impression ‐ Improvement Scale; CS: Columbia Scale; DESI: Disorders of Extreme Stress Inventory; DES: Dissociative Experiences Scale; DGRP: Duke Global Rating for PTSD; DTS: Davidson Trauma Scale; EPI: Eyesenck Personality Inventory; HADS: Hospital Anxiety and Depression Scale; HAM‐A: Hamilton Anxeity Scale; IPP: Inventory of Personal Problems; MADRS: Montgomery‐Asberg Depression Rating Scale; MISS: Mississippi Scale for Combat‐Related PTSD; NI: Newcastle Index; OCDS: Obsessive Compulsive Drinking Scale; PDS: Posttraumatic Stress Disorder Scale PSQI: Pittsburgh Sleep Quality Index; PSS: PTSD Symptoms Scale; RSD: Raskin Scale for Depression; SADS: Schedule for Affective Disorders and Schizophrenia; SAS: Simpson‐Angus Scale; SCID: Structured Clinical Interview for DSM; SCID‐P: Structured Clinical Interview for DSM, Psychotic screen; SCL‐90‐R: Hopkins 90‐item Symptom Checklist‐Revised; SDS: Sheehan Disability Scale; SI‐PTSD: DSM based PTSD scale; SIP: Structured Interview for PTSD; SPRINT: Short PTSD Rating Interview scale; TLFB: Time‐Line Follow‐Back; VS: Vulnerability to the effects of stress scale; VAS: Visual Analog Scale; UKUSERS: UKU Side Effect Rating Scale; SPRINT: Short PTSD Rating Interview; TOP‐8: Treatment Outcome PTSD Scale