Banga 2003.
Methods | Study design: prospective, randomised, clinical study | |
Participants |
Diagnosis: acutely manic participants Method of diagnosis: not described Age: age 36.3 years +/‐ 10.8 years Sex: not described Location: Lady Hardinge Medical College, New Delhi Co‐morbidities: not described Adjunctive therapy: not described Adjunctive medication: not described |
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Interventions | Participants were randomly assigned to either: lithium or valproate Experimental arm n = 15 Duration: 21 days Treatment protocol: lithium was started in a dose of 300 mg twice daily, which was increased to 450 mg twice daily in the first week. Further change in doses were carried out at weekly intervals, guided by clinical improvement and treatment‐emergent adverse events . Therapist/face‐to‐face contact: not described Comparator arm n = 15 Duration: 21 days Treatment protocol: valproate was started in dose of 20 mg/kg/day. Further change in doses were carried out at weekly intervals, guided by clinical improvement and treatment‐emergent adverse events. Therapist/face‐to‐face contact: not described |
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Outcomes |
Primary outcome: > 50% fall in total YMRS from baseline to end of study was taken as a response Secondary outcomes: number and type of adverse events |
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Notes | Nil | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition |
Selective reporting (reporting bias) | High risk | Primary outcome data well reported. Adverse events outcomes poorly reported. |
Other bias | Unclear risk | None identified |