McIntyre 2000.

Methods	DESIGN Description: randomised, single‐blind trial (raters were blinded). BLINDING Participants: no Assessors: yes Administrators: no ALLOCATION CONCEALMENT No information available RANDOMISATION Method: participants were randomised (no other information provided)
Participants	SAMPLE Description: 36 patients with DSM‐IV diagnosis of bipolar I or II (depressive phase). Participants were 18 to 70 years of age. Exclusion criteria: prior exposure to trial drugs, substance dependence in past 30 days, ECT in preceding 4 weeks prior to entry or at any time during the trial, high suicide risk, history of nephrolithiasis, history of seizures, active neurological or medical problems, incapacity to provide consent, psychotic symptoms. SCREENING Primary diagnosis: SCID‐I/P version 2.0
Interventions	Interventions: 8‐week trial of topiramate vs bupropion SR adjunctive therapy with 18 participants in each arm. Topiramate 50 mg/day or bupropion SR 100 mg/day. Titrated every 2 weeks until clinical response. Final dose range: topiramate 50 to 300 mg/day; bupropion SR 100 to 400 mg/day. Participants were allowed to titrate to lower doses to enhance tolerability. Interventions added to existing treatments. For those participants randomised to topiramate, 5 received lithium, 13 received divalproex sodium, and 3 received atypical antipsychotics. For those participants randomised to bupropion SR, 8 received lithium, 10 received divalproex sodium, and 3 received atypical antipsychotics
Outcomes	Primary outcomes: the primary efficacy measure was the percentage of participants responding to treatment as measured by: 50% reduction from baseline in HDRS‐17; remission defined as endpoint HDRS‐17 score of less than or equal to 7. Secondary outcomes: the secondary efficacy measures were MADRS, CGI‐S, and CGI‐I results, but these were not detailed in the published account. Safety evaluation was assessed by report of adverse events, concomitant medications, vital signs, weight change, and laboratory tests. Data estimation: data were analysed on an intent‐to‐treat basis using LOCF. Independent t tests and analysis of variance (ANOVA) repeated measures design were used to compare baseline and 8 weeks of single‐blind treatment with topiramate and bupropion SR
Notes	INDUSTRY SUPPORT Industry funded: not specified Medication provided by industry: not specified Any of the authors work for industry: not specified
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information available to make judgement, e.g. "subjects were randomised to receive either."
Allocation concealment (selection bias)	Unclear risk	No information available to make judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	This was a single‐blind study. Performance bias due to knowledge of the allocated interventions by participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to make judgement, e.g. “single‐blind (rater‐blind)”
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition and reason for attrition are reported, attrition rate is balanced in numbers across intervention groups. LOCF used to account for missing data
Selective reporting (reporting bias)	Low risk	All expected outcomes in terms of efficacy and safety are reported. All the study's prespecified outcomes are reported
Other bias	Unclear risk	It is not specified if this study was industry funded