Ichim 2000.

Methods	Study design: a double‐blind, parallel, randomised controlled trial
Participants	Diagnosis: an acute manic episode Method of diagnosis: DSM‐ IV criteria for the manic phase of bipolar disorder on a structured clinical interview Age: for lithium, median = 31.9 years (SD =not given); for lamotrigine, median = 33.6 years (SD =not given); range = between 20 ‐ 59 years. Sex: for lithium 7 women; 8 men, for lamotrigine 7 women, 8 men. Location: South Africa Co‐morbidities: no information provided Adjunctive therapy: none Adjunctive medication: lorazepam (4–12 mg daily) was given when necessary for the control of aggression. No other psychotropic medication was permitted during the course of the study.
Interventions	Participants were randomly assigned to either: Experimental arm ‐ lithium N = 15 Duration: 28 days Treatment protocol: lithium was administered at a dose of 400 mg twice daily. Mean lithium level was 0.743 mmol/L. Therapist/face‐to‐face contact: not described Comparator arm ‐ lamotrigine N = 15 Duration: 28 days Treatment protocol: "Lamotrigine was given once daily at night, with a titration schedule consisting of a daily dose of 25 mg for 1 week, increasing to 50 mg in the second week and then to 100 mg in the third week. To maintain study blinding, the lamotrigine group also received a morning placebo" Therapist/face‐to‐face contact: not described
Outcomes	Timepoints for assessment: week 0, 1, 2, 3, 4 Primary outcome: Mania Rating Scale Secondary outcome: Discontinuation BPRS CGI Severity scale GAF Scale > 50% reduction in the MRS Score > 50% reduction in the BPRS Score CGI severity score of 1 or 2 Additional medication
Notes	Date of study: not given Funding source: the authors wish to thank… GlaxoWellcome for the supply of lamotrigine samples. Declarations of interest among the primary researchers: none described
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"randomised"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Unclear risk	"To maintain study blinding, the lamotrigine group also received a morning placebo, and lithium monitoring was carried out by an independent clinician. No other description. Not described."
Incomplete outcome data (attrition bias) All outcomes	Low risk	5/30 discontinued
Selective reporting (reporting bias)	Low risk	Well described
Other bias	Low risk	None identified