Baker 1995.

Study characteristics
Methods	Design: multi‐centre trial, randomised, placebo‐controlled, comparative, parallel, flexible dose, double‐blind Duration of intervention: 12 weeks Placebo run‐in: single‐blind placebo run‐in excluded 28 placebo‐responders Post‐treatment: Not specified
Participants	Setting: United States of America Sample size: 118 randomised to brofaromine and placebo Mean age: 44 years (23 ‐ 73). Sex: 92 men and 22 women (for 114 participants), MDD not present, 60% combat‐related Diagnostic measure: DSM‐III‐R Inclusion criteria: Quote: “One hundred and forty‐six outpatients of both sexes, civilians and veterans, ages 23 73, all with PTSD, were enrolled in the study. In addition to meeting DSM‐III‐R criteria for PTSD, patients were required to have a minimum Clinician Administered PTSD Scale (CAPS) score of 45, a maximum Montgomery‐Asberg Depression Scale (MADRS) score of 22 and to be symptomatic for at least 6 months. The types of trauma reported were varied” Exclusion criteria: Quote: “Women of child‐bearing potential were excluded, as were those with comorbid medical or psychiatric conditions, at immediate risk of suicide, in active pursuit of compensation, receiving other forms of active treatment such as psychotherapy, or with a known sensitivity to MAOIs. Participating patients could not receive psychotropic medication except for low‐dose choral hydrate, diphenhydramine, hydroxyzine, and benzodiazepines under specified conditions. Placebo responders, i.e., patients who showed a 30% or more improvement in the CAPS score between the screening and baseline visits, were excluded, leaving a total of 118 patients entered into the active treatment phase of the study” Comorbidity: MADRS Dropouts: 35/118 (insufficient information to determine dropout rates for the 2 groups separately)
Interventions	Pharmacological intervention: Quote: “The 12‐week trial, conducted at 12 centers throughout the country, utilized a randomized, double‐blind, flexible dose, comparative design with two parallel groups. Eligible patients were randomized to receive either brofaromine, titrated up to 150 mg, or placebo"
Outcomes	Primary outcome: CAPS Secondary outcomes: IES, DTS, CGI Time points: Quote: “Safety and efficacy assessments were performed during the screening visit, at baseline, weekly at the end of weeks 1 through 4, and every other week at the end of weeks 6 through 12"
Notes	Dates of trial: Not stated Industry‐funded: Not mentioned Medication provided by industry: No Any of the authors work for industry? Yes Obtained additional HAM‐D and CAPS‐2 summary statistics from Sudie Back
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: "The 12‐week trial, conducted at 12 centers throughout the country, utilized a randomized, double‐blind, flexible dose, comparative design with two parallel groups"
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: "Large multi‐center, double‐blind, parallel trial to assess the efficacy of brofaromine in the treatment of post traumatic stress disorder (PTSD) failed to show a significant difference between the brofaromine and placebo treatment groups"
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	There was insufficient information to determine dropout rates for the 2 groups separately. Overall 29% of the participants dropped out of the study. Reasons for treatment withdrawal were provided for only 12 participants in the treatment group and only reasons given for 6 participants in the placebo group. The characteristics of the sample did not differ at baseline. All analyses were intention‐to‐treat (ITT) Quote: “Treatment groups were well matched on demographic and baseline variables, although patients in the placebo group were somewhat younger. Of the 35 patients who discontinued the study prematurely, ten brofaromine and six placebo patients did so because of adverse experiences with the medication. One patient in the brofaromine study was discontinued because of abnormal laboratory values”
Selective reporting (reporting bias)	Unclear risk	The study protocol was not available for this study
Other bias	Low risk	No other sources of bias were identified