Liu 2003.
Methods | Allocation: randomised Blinding: open label Duration: 8 weeks (wash‐out period: 3‐7 days) Design: parallel Country: China |
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Participants | Diagnosis: CCMD‐3 schizophrenia n = 60 Sex: male only Age: not stated, but likely to be adult, as their illness onset age is reported as 25 ± 5.27 years History: mean duration of illness: 14.73 ± 5.59 years Setting: inpatient |
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Interventions | 1. Sodium valproate + clozapine: valproate fixed dose of 600 mg/day. n = 30 2. Clozapine: dosage unclear. n = 30 |
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Outcomes | Leaving the study early: acceptability/tolerability of treatment Clinical response: mental state (BPRS total) Unable to use: Adverse events: no information provided |
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Notes | All participants took clozapine+placebo during wash‐out No information about the dosage of clozapine provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned in a 1:1 ratio", p11596 |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | We don't think blinding causes significant bias in objective outcomes |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | No information about blinding provided, assume open‐label |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | We don't think blinding causes significant bias in objective outcomes |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | No information about blinding provided, assume open‐label |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Three and four participants left early from the experiment and control groups respectively. Valproate group: 3/30 = 10%, monotherapy group: 4/30 = 13.3%, no reason provided for people leaving the study early. They are not included in the final analysis. (p 11,596) |
Selective reporting (reporting bias) | High risk | Adverse events not reported |
Other bias | Low risk | None obvious |