SKB650.

Study characteristics
Methods	Design: randomised, placebo‐controlled, parallel, fixed‐dose, double‐blind, relapse prevention Duration of intervention: 252 days (mean) Placebo run‐in: Yes Post‐treatment: Not specified
Participants	Setting: Not stated Sample size: 176 randomised to paroxetine and placebo Mean age: 43 (18 ‐ 82 years) Sex: 59 men and 114 women Diagnostic measure: DSM‐IV Inclusion criteria: Quote: “100% PTSD by DSM‐IV" Exclusion criteria: Quote: “<50 CAPS at baseline, Axis I disorder diagnosis, depressive episode preceeding PTSD diagnosis, CGI decreasing by 2 or more points between screening & baseline, likely to exaggerate symptoms, placebo run‐in compliance of < 80% or >120% at baseline visit, abnormal ECG not resolved by baseline, psychotropic drugs not discontinued according to cut‐offs, herbal treatments, investigational drugs within 3 months prior to screening, ECT within 3 months prior, intolerance to any SSRI, psychotherapy 12 wks prior, substance abuse/dependence within 6 months, suicidal risk, pregnancy, not practising contraception, serious medical disorder, previous participation in similar studies, judged as unable to comply to instructions" Comorbidity: Unclear Dropout rates: 46/176 (21/88 in the paroxetine and 25/88 in the placebo group)
Interventions	Pharmacological intervention: Quote: “Paroxetine ‐ Maximum dose 50mg/day"
Outcomes	Outcomes: CAPS‐2, DTS, MADRS, SDS (no distinction made between primary and secondary outcomes) Time points: No information Data estimation: ITT and LOCF
Notes	Dates of trial: Not stated Industry‐funded: No information Medication provided by industry: No information Any of the authors work for industry: No information
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	It was reported that the patients were randomised but no mention is made of the method of randomisation Quote: "Study Type: RCT"
Allocation concealment (selection bias)	Unclear risk	There was insufficient information provided to determine if study medication allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	The study was described as "double‐blind", although no information was provided on which parties were blinded and how blinding was achieved Quote: "Blindness: Double blind".
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The study was described as "double‐blind", although no information was provided on blinding of outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	A similar proportion of participants withdrew from the paroxetine group (21/88, 24%) compared to the placebo group (25/88, 28%). Reasons for withdrawals were not provided. No information was provided on whether the 2 groups differed by sample characteristics at baseline and endpoint. Data estimation for ITT and LOCF analysis
Selective reporting (reporting bias)	Unclear risk	The study protocol was not available for this study
Other bias	Unclear risk	Insufficient information to determine other sources of bias