Small 1988.

Methods	Study design: randomised controlled study
Participants	Diagnosis: of bipolar disorder presenting in manic or mixed phases Method of diagnosis: DMS‐III criteria for a manic episode Age: mean age of 37.4 years Sex: women; men. but no figures provided Location: USA Co‐morbidities: not described Adjunctive therapy: not described Adjunctive medication: not described
Interventions	Participants were randomly assigned to either: Experimental arm ‐ lithium N = 17 Duration:8 weeks Treatment protocol: A 10‐14 day washout of prior psychotropic medications was undertaken. Lithium carbonate was titrated to achieve plasma levels between 0.6‐1.5mmol/l. Therapist/face‐to‐face contact: not described Comparator arm ‐ Electroconvulsive therapy N = 17 Duration: 8 weeks Treatment protocol: "After completion of the baseline evaluations, participants were randomly assigned to treatment with lithium carbonate or ECT. At first, unilateral non‐dominant ECT was the form of treatment prescribed with the option of the attending psychiatrist to switch to bilateral treatment if therapeutic response was judged inadequate or difficulties were encountered with seizure induction. However, the first six manic participants randomised to ECT demonstrated little or no therapeutic benefit, and some participants’ condition actually worsened with unilateral ECT. At that point, the design was changed so that bilateral ECT was administered form the onset of treatment. The participants who underwent ECT received a series mean of nine treatments over three to five weeks." Therapist/face‐to‐face contact: not described
Outcomes	Timepoints for assessment: weeks 0‐8 Primary outcome: Clinical global impression Secondary outcome: MRS Shopsin Gershon Social Behaviour checklist Severity of depression scale Hamilton depression scale BPRS NOSIE GAS
Notes	Funding source: this study was supported in part by grant MH40930 from… Institute of Mental Health, Bethseda, Md (Dr J G Small)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"random"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	High risk	ECT – not possible. The raters tried to avoid learning which treatment the participants received, but this was not always possible.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not described
Selective reporting (reporting bias)	Low risk	Well reported
Other bias	Low risk	None identified