Tucker 2007.

Study characteristics
Methods	NEW TRIAL ADDED TO UPDATED REVIEW Design: single‐centre, randomised, placebo‐controlled, parallel, flexible‐dose, double‐blind Duration of intervention: 8 weeks Placebo run‐in: washout/screening (up to 30 days before randomisation) Post‐treatment: 4 weeks maintenance
Participants	Setting: Quote: “Outpatient mental health setting associated with the University of Oklahoma Health Sciences Center, Oklahoma City" Sample size: 40 randomised to topiramate and placebo Mean age: 38.5 years (SD: 10.5) (18 ‐ 64) Sex: 8 men and 30 women (for 38 participants), non‐combat, 23 MDD (61%) Diagnostic measure: DSM‐IV (SCID‐IV, CAPS) Inclusion criteria: Quote: “Selection criteria included men and nonpregnant women 18 to 64 years of age with a diagnosis of civilian, non‐combat‐related Axis I PTSD for greater than 6 months according to DSM‐IV criteria as measured by Structured Clinical Interview for DSM‐IV (SCID‐IV) and with a CAPS score ≥50. Women had to be postmenopausal or practicing reliable contraception" Exclusion criteria: Quote: "Patients with major organic psychiatric diseases, current substance dependence or abuse (excluding nicotine or caffeine), serious or unstable concurrent illness, medical conditions potentially affecting drug absorption, history of nephrolithiasis or seizures, reduced renal clearance, elevated serum liver enzyme levels, current enrolment in cognitive behavioural therapy program, a history of primary major depressive disorder or primary major anxiety disorder, or known hypersensitivity to or a prior adverse event with topiramate were excluded from the study. Pregnant or lactating women were also excluded" Comorbidity: MD, MD + panic, MD + dysthymia Dropout rates: 8/38 (5/19 in the topiramate and 3/19 in the placebo group)
Interventions	Pharmacological intervention: Quote: “Study medication was started at 25 mg/day and was titrated by 25‐50 mg/week during an 8‐week period following a designated washout period for protocol‐prohibited medications, which included all psychotropic medications. Patients were titrated to their maximum tolerated dose until complete or nearly complete efficacy was achieved or until the maximum dosage allowed (400 mg/day) was reached. Topiramate was given twice daily"
Outcomes	Primary outcomes: CAPS‐17 Secondary outcomes: HRSA, HRSD, TOP‐8, CGI, DTS, BIS, SDS, CD‐RISC, SFQ Time points: No information Data estimation: ITT with LOCF
Notes	Dates of trial: Quote: “Patients participated in this study between April 26, 2002, and February 4, 2004" Industry‐funded: Yes. Quote: "This study was supported by Ortho‐McNeil Neurologics, Inc., Titusville, NJ" Medication provided by industry: No information Any of the authors work for industry: Yes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomly assigned to receive either placebo (N=20) or topiramate (N=20) in a 1:1 ratio using computer generated codes; randomization was balanced using permuted blocks”
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
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	Low risk	More participants withdrew from the placebo group (3/20; 15%) compared to the topiramate (5/20; 25%) group. Common withdrawals include adverse events and patient choice. However, the 2 groups did not differ by sample characteristics at baseline and the ITT population was used at baseline and endpoint Quote: "The efficacy and safety population comprised 38 patients (topiramate, N=19; placebo, N=19). Demographic characteristics, comorbid Axis I condition secondary to PTSD, and trauma type were similar between groups .... Efficacy was analysed in the intention‐to‐treat population that included all randomised patients who had taken ≥1 dose of study medication and had ≥1 post baseline efficacy evaluation"
Selective reporting (reporting bias)	Unclear risk	The study protocol was not available for this study
Other bias	Unclear risk	Funding for study provided by industry Quote: "This study was supported by Ortho‐McNeil Neurologics, Inc., Titusville, NJ"