Jia 2007.
| Methods | Allocation: randomised Blinding: open label Duration: 4 weeks Design: parallel Country: China |
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| Participants | Diagnosis: ICD‐10 schizophrenia n = 80 Sex: male only Age: 18‐50 years, mean 38.9 ± 11.0 years History: duration of illness total, range 10‐25 years, mean 15.3 ± 9.1 years Setting: inpatient. |
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| Interventions | 1. Sodium valproate + clozapine: valproate 400‐800 mg/d, clozapine dosage unclear; n = 40 2. Clozapine alone: dosage not reported; n = 40 |
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| Outcomes | Clinical response: mental state (PANSS total)
Adverse events: various events Unable to use: Clinical response: positive symptoms, negative symptoms ‐ PANSS subscales (skewed data) Leaving the study early (no information provided) Adverse events: TESS scores (no means and SDs reported) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly assigned", p 3 "Pairs of participants with no significant differences in age, BMI, duration of illness, smoking, Clozapine dosage taken, co‐medication and PANSS score", were randomly divided into two equal groups" |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Not stated. No information about blinding provided, therefore assuming open‐label |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Not stated. No information about blinding provided, therefore assuming open‐label |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Not stated |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated |
| Selective reporting (reporting bias) | High risk | TESS scores measured but no means and SDs reported; study authors only stated that no significant difference in TESS score between groups (P > 0.05). Study authors also selectively reported binary outcomes of a few adverse events, but didn't provide numbers for all adverse events |
| Other bias | Unclear risk | None obvious |