Casey 2003.
| Methods | Allocation: randomised Blinding: double Duration: 28 days (preceded by wash‐out period of 3 times the mean elimination half‐life of the antipsychotic) Design: parallel Country: USA |
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| Participants | Diagnosis: DSM‐IV schizophrenia n = 249* Sex: 184 M, 58 F* Age: ˜ 39 years History: treated with antipsychotic at the time of enrolment (n = 214) |
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| Interventions | 1. Olanzapine: starting dose 5 mg/d, increased to 10mg/d on day 3 and to target dose of 15 mg/d on day 6; n = 65* 2. Risperidone: starting dose 2 mg/d, increased to 4 mg/don day 3 and to target dose of 6 mg/d on day 6; n = 60* 3. Olanzapine + divalproex: olanzapine was titrated as described in 1. Divalproex starting dose 15 mg/d, titrated to clinical response (maximum 30 mg/d); n = 66* 4. Risperidone + divalproex: risperidone was titrated according to 2. and divalproex according to 3; n = 58* | |
| Outcomes | Clincally significant response: important change (PANSS reduction > 20%)
Leaving the study early: acceptability/tolerability of treatment Clinical response: mental state (PANSS total), positive symptoms (PANSS subscale) Adverse events: at least one event, various events Unable to use: Clinical response: mental state ‐ BPRS (no data), aggression/agitation ‐ PANSS‐EC (data skewed) Adverse events: SAS, AIMS, BAS scores (no data) |
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| Notes | *The 2 groups with combination therapy and the 2 groups with monotherapy were considered to be one (p 185, Table 1) NB. In the original report 7 participants were not included in the ITT analyses due to missing on‐treatment PANSS score (n = 4) and randomisation at 2 sites (only the second randomisation was excluded; n = 3) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomized" (p 182) no further description |
| Allocation concealment (selection bias) | Unclear risk | Not indicated |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | "double‐blind" (p 182) |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | "double‐blind" (p 182) |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | "double‐blind" (p 182) |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | "double‐blind" (p 182) |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition data for different treatment groups for the reasons of treatment‐emergent adverse events and lack of efficacy were reported and distributed relatively even between groups, but there were no data for the total number of people leaving the study in different treatment groups. |
| Selective reporting (reporting bias) | High risk | No data for those leaving the study early for the different treatment groups; BPRS and movement adverse effect were not reported |
| Other bias | Unclear risk | The 2 groups with combination therapy and the 2 groups with monotherapy were considered to be 1 In the original report 7 people with schizophrenia were not included in the ITT analyses due to missing on‐treatment PANSS score and randomisation at 2 sites (only the second randomisation was excluded) |