Wassef 2000.
| Methods | Allocation: randomised Blinding: double Duration: 21 days Design: parallel Country: USA |
|
| Participants | Diagnosis: chronic schizophrenia (Research Diagnostic Criteria) n = 12 Sex: 7 M, 5 F Age: mean ˜ 28,6 years History: discontinued standard oral antipsychotic drugs > 3 weeks prior to trial, discontinued depot neuroleptics > 5 weeks prior to trial, no substance abuse, no seizures, normal EEG Setting: inpatients |
|
| Interventions | 1. Haloperidol + valproate: haloperidol starting dose 10 mg/d, increased to 15 mg/d after 3 days, valproate dose adjusted to target plasma level 75‐100 µg/ml; n = 5 2. Haloperidol + placebo: haloperidol starting dose 10 mg/d, increased to 15 mg/d after 3 days; n = 7 | |
| Outcomes | Leaving the study early: acceptability/tolerability of treatment Clinical response: mental state (BPRS total) Unable to use: Clinical response: global state ‐ CGI (only P values reported); negative symptoms ‐ SANS (skewed data) |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomized" (p 357) |
| Allocation concealment (selection bias) | Unclear risk | Not indicated |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | "double‐blind" (p 357); "identical appearing tablets"; "doses were adjusted by an unblinded investigator who was not involved in medication assignment, participant assessment or clinical care. Dose adjustments were done in a blinded fashion" (p 358) |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | "double‐blind" (p 357); "identical appearing tablets"; "doses were adjusted by an unblinded investigator who was not involved in medication assignment, participant assessment or clinical care. Dose adjustments were done in a blinded fashion" (p 358) |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | "double‐blind" (p 357); "identical appearing tablets"; "doses were adjusted by an unblinded investigator who was not involved in medication assignment, participant assessment or clinical care. Dose adjustments were done in a blinded fashion" (p 358) |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | "double‐blind" (p 357); "identical appearing tablets"; "doses were adjusted by an unblinded investigator who was not involved in medication assignment, participant assessment or clinical care. Dose adjustments were done in a blinded fashion" (p 358) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No people leaving the study early |
| Selective reporting (reporting bias) | Low risk | No selective reporting |
| Other bias | Low risk | No other bias |