Garfinkel 1980.

Methods	Study design: double‐blind, parallel, randomised controlled study
Participants	Diagnosis: bipolar disorder, manic episode Method of diagnosis: past history of bipolar illness and met criteria of Feighner for mania by unanimous agreement of the 3 investigating psychiatrists. Age: for lithium, median = 41.5 (SD = 5.8) years; for haloperidol, median = 37.0 (SD = 5.3) years; for lithium and haloperidol, median = 37.0 (SD = 6.1) years Sex: lithium 5 women; 2 men; haloperidol 3 women; 4 men; haloperidol and lithium 4 women; 3 men. Location: Clarke Institute of Psychiatry Co‐morbidities: not described Adjunctive therapy: none Adjunctive medication: chloral hydrate was the only bedtime hypnotic permitted.
Interventions	Participants were randomly assigned to either: Experimental arm ‐ lithium N = 7 Duration: 3 weeks Treatment protocol: "Subjects (in each group on day 1) received 3 capsules of lithium carbonate (300 mg each) and 3 placebo capsules identical in size, shape and colour to the haloperidol capsules, After the first day the dosage of these medications was varied according to the response or the appearance of untoward effects (Table 2). lithium blood levels were obtained on all participants at weekly intervals." Therapist/face‐to‐face contact: N/A Comparator arm ‐ haloperidol N = 7 Duration: 3 weeks Treatment protocol: "3 capsules of haloperidol (10 mg each) and 3 placebo capsules identical to the lithium capsules, After the first day the dosage of these medications was varied according to the response or the appearance of untoward effects (Table 2). lithium blood levels were obtained on all participants at weekly intervals." Therapist/face‐to‐face contact: not described Comparator arm ‐ lithium and haloperidol N = 7 Duration: 3 weeks Treatment protocol: "3 capsules of haloperidol (l0 mg each) and 3 capsules of lithium carbonate (300 mg). After the first day the dosage of these medications was varied according to the response or the appearance of untoward effects (Table 2). lithium blood levels were obtained on all participants at weekly intervals." Therapist/face‐to‐face contact: not described
Outcomes	Timepoints for assessment: day 1, twice weekly for 3 weeks Primary outcome: BPRS Secondary outcome: EPS Neurological Rating Scale
Notes	Date of study: Funding source: McNeil Laboratories kindly provided haloperidol, matching placebo and financial assistance for the investigation Declarations of interest among the primary researchers: not described
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Twenty‐one subjects who met these criteria were randomly assigned to one of 3 treatment groups"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Low risk	"lithium blood levels were obtained on all participants at weekly intervals. All personnel involved in patient ratings were unaware of the lithium blood levels, these being known only to the laboratory staff and the non‐blind psychiatrist who was allowed to recommend changes in lithium or placebo dose to the blind (treating) psychiatrist. Ratings of the patient’s clinical state were made by an off ward research nurse blind to medication groups"
Incomplete outcome data (attrition bias) All outcomes	Low risk	No attrition
Selective reporting (reporting bias)	Low risk	None identified
Other bias	Low risk	None identified