Trivedi 1996.
| Methods | Study design: open‐label, randomised study | |
| Participants |
Diagnosis: diagnosed as bipolar disorder ‐ mania Method of diagnosis: according to DSM‐III‐R criteria Age: "adults" Sex: female 8; male 35 Location: Department of Psychiatry, K.G.'s Medical College, Lucknow Co‐morbidities: not described Adjunctive therapy: not described Adjunctive medications: not described |
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| Interventions | Participants were randomly assigned to either: Experimental arm ‐ lithium N = 11 Duration: 28 days Treatment protocol: "On day 'O' the selected participants were started on lithium (900 mg/day). Oral diazepam was given on SOS basis. The participants continued on the same medication, subject to appearance of serious side‐effects when the dosage were reduced, till day 21. By this time, if a reduction of 50% of the initial BRMS score was not achieved, the dose was increased to 1200 mg/day Therapist/face‐to‐face contact: not described Comparator arm ‐ carbamazepine N = 14 Duration: 28 days Treatment protocol: "On day 'O' the selected participants were started on carbamazepine (200 mg/day) which was built up to 800 mg/day by the end of first week. Oral diazepam was given on SOS basis. The participants continued on the same medication, subject to appearance of serious side‐effects when the dosage were reduced, till day 21. By this time, if a reduction of 50% of the initial BRMS score was not achieved, the dose was increased to 1200 mg/day. Therapist/face‐to‐face contact: not described Comparator arm ‐ haloperidol Duration: 28 days Treatment protocol: "On day 'O' the selected participants were started on haloperidol (15 mg/day). Oral trihexyphenidyl (6 mg/day) was also given. Oral diazepam was given on SOS basis. The participants continued on the same medication, subject to appearance of serious side‐effects when the dosage were reduced, till day 21. By this time, if a reduction of 50% of the initial BRMS score was not achieved, the dose ws increased to 20 mg/day. |
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| Outcomes |
Timepoints for assessment: days 7, 14, 21, and 28 Primary outcome:
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| Notes | ‐ | |
| 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 | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Out of 61 participants selected for the study only 43 (male = 35, female = 8) completed the study |
| Selective reporting (reporting bias) | Unclear risk | Well reported |
| Other bias | Low risk | None identified |
AIMS: Abnormal Involuntary Movement Scale; BMD‐I: bipolar mood disorder‐I; BMI: body mass index; BPRS: Brief Psychiatric Rating Scale; BRMS: Bech‐Rafaelsen Mania Scale; CGI‐C; Clinical Global Impression‐change; CGI‐S: Clinical Global Impression‐severity; CIDI: Composite International Diagnostic Interview; CDRS: Children's Depression Rating Scale; CGAS: Children's Global Assessment Scale; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, fourth edition; ECT: electroconvulsive therapy; EPS: extrapyramidal symptoms; g: gram; GAF: Global Assessment of Functioning; GAS: Global Assessment Scale; IMPS: Inpatient Multidimensional Psychiatric Scale; kg: kilogram; KMRS: School‐Age Children Mania Rating Scale; Li: lithium; MADRS: Montgomery‐Åsberg Depression Rating Scale; MAS: Modified Ashworth Scale; mEq/L: milliequivalents per litre; mg: milligram; mg/mL: milligram per millilitre; MINI: Mini International Neuropsychiatric Interview; mmol/L: millimoles per litre; MRS: Mania Rating Scale; MSRS: Manic‐State Rating Scale; n: number; NOSIE: Nurses' Observation Scale for Inpatient Evaluation; N/A: not applicable; PANSS: Positive and Negative Syndrome Scale; PEF: peak expiratory flow; PIP: Personal Independence Payment; SADS: Schedule for Affective Disorders and Schizophrenia; SAS: Simpson Angus Scale; SCID: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth edition; SD: standard deviation; μg/mL: microgram per millilitre; VPA: valproate; YMRS: Young Mania Rating Scale