Gouliaev 1996.

Methods	Study design: single‐blind, parallel, randomised controlled study
Participants	Diagnosis: DSM‐111‐R episode with or without psychotic symptoms in need of antimanic treatment were included. Method of diagnosis: SADS Age: for lithium + clonazepam, median = 41.6 (SD = 11.9); for zuclopenthixol + clonazepam, median = 36.9 (SD = 11.9); range = 21 ‐ 64 Sex: lithium + clonazepam 9 women; 6 men, zuclopenthixol + clonazepam 8 women; 5 men. Location: psychiatric Hospital in Aarhus, Denmark Co‐morbidities: not described Adjunctive therapy: none Adjunctive medication: clonazepam as needed
Interventions	Participants were randomly assigned to either: Experimental arm ‐ lithium + clonazepam N = 14 Duration: 28 days Treatment protocol: "Patients received initially 12 mEq lithium citrate twice daily, and subsequent dosing adjustment was made to achieve serum lithium level of 0.9‐1 mEq/L. Clonazepam was given twice daily at a fixed dose of 1mg in the morning and 2 mg in the evening. Clonazepam as additional per need medication was allowed in the first week only with doses up to extra 2 mg daily. No other drugs were allowed." Therapist/face‐to‐face contact: not described Comparator arm ‐ zuclopenthixol + clonazepam N = 14 Duration: 28 days Treatment protocol: "Patients received oral zuclopenthixol at a fixed daily dose of 10 mg in the morning and 10 mg in the evening. Serum levels of zuclopenthixol were measured weekly. Clonazepam was administered the same way, as described for the other group. In case of extrapyramidal symptoms additional medication with orphenadrine was allowed. After 28 days of treatment participants were referred to a standard treatment regime." Therapist/face‐to‐face contact: not described
Outcomes	Timepoints for assessment: 0, 3 , 6, 13, 20, 27 days Primary outcome: BRMS Secondary outcome: Response ‐ The main outcome measure for drug response was defined as a 50% or more reduction in BRMS mania score Additional medication Remission of hallucinations or delusions Withdrawal Side effect rating scale Clients Satisfaction Questionnaire BRMS (missing data) BPRS (missing data) CGI (missing data)
Notes	Date of study: 1990 ‐ 1992 Funding source: this study was supported by the Danish Trust for Psychiatric Research. 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	"randomly" allocated
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	High risk	The study design was single‐blind, with the rater being blind to treatment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	4/28 withdrew
Selective reporting (reporting bias)	High risk	Poor coverage of reporting
Other bias	Low risk	None described