Shafti 2008.

Methods	Study design: a randomised, double‐blind, parallel‐group study, parallel
Participants	Diagnosis: bipolar I disorder, manic episode Method of diagnosis: according to the DSM‐IV Age: not described Sex: 30 women; 0 men Location: not described Co‐morbidities: not described Adjunctive therapy: not described Adjunctive medication: "Although using benzodiazepine (lorazepam) and typical antipsychotic (haloperidol) as adjunctive agents were permissible during study, neither combining anticonvulsant nor atypical antipsychotic was prescribed throughout the aforesaid assessment. In addition, no psychosocial intervention other than ordinary care was used through this phase."
Interventions	Participants were randomly assigned to either: Experimental arm ‐ lithium N = 15 Duration: 3 weeks Treatment protocol: "The first group (n = 15) was designated to lithium carbonate (300 mg uncoated tablets) as the solitary antimanic agent, whereas the second one (n = 15) was chosen for prescription of valproate sodium (200 mg coated tablets) for the same aim. Both drugs were prescribed according to practice guidelines and standard‐titration protocols The tablets were prescribed while previously inserted into empty and similar capsules, which were prepared in this regard to make participants blind with respect to the procedure. The evaluators were also unaware concerning the aforesaid partition and the type of medications arranged for each group.Mean serum level of lithium was 0.87 mmol/L." Therapist/face‐to‐face contact: as above Comparator arm ‐ valproate N = 15 Duration: 3 weeks Treatment protocol: "The first group (n = 15) was designated to lithium carbonate (300 mg uncoated tablets) as the solitary antimanic agent, whereas the second one (n = 15) was chosen for prescription of valproate sodium (200 mg coated tablets) for the same aim. Both drugs were prescribed according to practice guidelines and standard‐titration protocols The tablets were prescribed while previously inserted into empty and similar capsules, which were prepared in this regard to make participants blind with respect to the procedure. The evaluators were also unaware concerning the aforesaid partition and the type of medications arranged for each group."
Outcomes	Timepoints for assessment: baseline and weekly Primary outcome: MSRS Secondary outcome: Premature discontinuation MSRS frequency + intensity CG‐S
Notes	Date of study: not given Funding source: the authors declare no funding or conflicts of interest. Declarations of interest among the primary researchers: the authors declare no funding or conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Random, 1:1 ratio – only description
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Low risk	"The tablets were prescribed while previously inserted into empty and similar capsules, which were prepared in this regard to make participants blind with respect to the procedure. The evaluators were also un‐ aware concerning the aforesaid partition and the type of medications arranged for each group."
Incomplete outcome data (attrition bias) All outcomes	Low risk	There was no premature discontinuation in neither of groups.
Selective reporting (reporting bias)	Low risk	Well reported
Other bias	Low risk	None identified