Clark 1996.
| Methods | Study design: single‐blind, parallel, randomised controlled study | |
| Participants |
Diagnosis: bipolar affective disorder manic phase Method of diagnosis: DSM IV Age: "matched" Sex: "matched" Location: not given Co‐morbidities: not described but exclusion criteria included other axis 1&2 disorders Adjunctive therapy: none Adjunctive medication: in the event of agitation not being controlled on the study medication, clothiapine, a low potency neuroleptic, at a dose of 40 ± 120 mg was given on an as‐needed basis to a maximum of 240 mg daily. Controlled seclusion periods were also an option in this situation. Extrapyramidal symptoms were treated with orphenadrine 50 ± 150 mg daily on as‐needed basis. |
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| Interventions | Participants were randomly assigned to either: Experimental arm ‐ lithium N = 20 Duration: 4 weeks Treatment protocol: participants were started on lithium at a dose of 250 mg three times a day, which was adjusted on an individual basis to achieve a blood level of 0.6 ± 1.2 mmol/L to a maximum of 1800 mg per day. Once the regimen was commenced, no other routine psychotropic medications were administered. Therapist/face‐to‐face contact: not described Comparator arm ‐ clonazepam N = 20 Duration: 4 weeks Treatment protocol: participants were started on clonazepam at a dose of 2 mg four times daily increasing as needed to a maximum of 16 mg per day. Once the regimen was commenced, no other routine psychotropic medications were administered |
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| Outcomes |
Timepoints for assessment: 3, 10, 21, 28 days Primary outcome:
Secondary outcome:
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| Notes |
Date of study: not described Funding source: not described Declarations of interest among the primary researchers: not described |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding (performance bias and detection bias) All outcomes | High risk | Authors admitted that it was possible blinding had been broken at times |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The study sample consisted of 15 participants on lithium and 15 participants on clonazepam. One participant in the clonazepam group absconded from the hospital on day 10 but was included in the analysis on an intend‐to‐treat basis |
| Selective reporting (reporting bias) | Low risk | Well reported |
| Other bias | Low risk | None identified |