Neppe 1983.
Methods | Allocation: randomised ‐ no further information. Blinding: double ‐ no further information. Design: cross‐over. Duration: 2 X 6 weeks (preceded by 3‐week baseline). Setting: in hospital. | |
Participants | Diagnosis: schizophrenia (10), non‐progressive dementia (2), rapid cycling (1) (diagnostic criteria unclear). N = 13.* Age: mean ˜34 years. Sex: 8 M, 5 F. History: chronic, "poor‐responders", EEG abnormalities. | |
Interventions | 1. Adjunctive carbamazepine: dose 600 mg/day + various antipsychotics (constant dose). N = 3. 2. Placebo adjunctive treatment + various antipsychotics (constant dose). N = 6. | |
Outcomes | 1. Leaving the study early.
2. Global impression (CGI).
3. Mental state (20%, 35%, 50% BPRS reduction). Unable to use: . General improvement (Global Assessment, OCR unpublished scales). |
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Notes | *Data extracted for 9 participants with schizophrenia from published data. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomized" (p.326), "random number list" (letter). |
Allocation concealment (selection bias) | Unclear risk | No information available. |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | "Double blind" (p.326). |
Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | "Double blind" (p.326). |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | "Double blind" (p.326). |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | "Double blind" (p.326). |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Two out of six patients in the control group compared to zero out of three in the intervention group dropped out [out of 13]" (p.327). |
Selective reporting (reporting bias) | High risk | No SDs for BPRS. |
Other bias | Low risk | No other bias ("one [subject had] a history of contaminating cannabis use", p.327). |