Shafti 2010.
Methods |
Study design: parallel group, double‐blind, randomised study |
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Participants |
Diagnosis: bipolar I disorder, manic episode Method of diagnosis: according to DSM‐IV‐TR diagnostic criteria Age: not described Sex: 40 women; 0 men Location: Tehran, Iraq Co‐morbidities: not described Adjunctive therapy: no Adjunctive medication: prescription of lorazepam, as a sedating agent, was allowed during assessment |
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Interventions | Participants were randomly assigned to either: Experimental arm ‐ lithium N = 20 Duration: 3 weeks Treatment protocol: "after 3–5 days washout period Patients in the first group (n = 20) were given lithium carbonate (300 mg uncoated tablets).The cases in the second group (n = 20) were prescribed olanzapine (5 mg uncoated tablets). Both of theses drugs were prescribed according to practice guidelines and standard titration protocols. no supplementary anticonvulsant or additional antipsychotic was permissible through‐ out the appraisal. Also no psychosocial intervention, except for usual care, was acceptable during evaluation. Upon completion of all baseline assessments, the tablets were prescribed. Identical‐looking capsules were prepared with the separate medication(s) to ensure the subjects in each group and the evaluator(s) were unaware of any distinction in the visual appearance, in the types of medication given in this study.Mean serum level of lithium 0.78 mmol/L." Therapist/face‐to‐face contact: as above Comparator arm ‐olanzapine N = 20 Duration: 3 weeks Treatment protocol: "after 3–5 days washout period Patients in the first group (n = 20) were given lithium carbonate (300 mg uncoated tablets).The cases in the second group (n = 20) were prescribed olanzapine (5 mg uncoated tablets). Both of theses drugs were prescribed according to practice guidelines and standard titration protocols. no supplementary anticonvulsant or additional antipsychotic was permissible through‐ out the appraisal. Also no psychosocial intervention, except for usual care, was acceptable during evaluation. Upon completion of all baseline assessments, the tablets were prescribed. Identical‐looking capsules were prepared with the separate medication(s) to ensure the subjects in each group and the evaluator(s) were unaware of any distinction in the visual appearance, in the types of medication given in this study." |
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Outcomes |
Primary outcome:
Secondary outcome:
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random assignment to olanzapine or lithium carbonate in a 1:1 ratio. |
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 | Three participants (15%) in the olanzapine group and two participants (10%) in the lithium group left the appraisal in the second half of the study due to unwillingness or adverse events of the prescribed drugs. |
Selective reporting (reporting bias) | Low risk | Well reported |
Other bias | Low risk | None identified |