Gross 1974.
Methods | Allocation: randomly assigned, no further information. Blindness: double (identical capsules). Design: 3 parallel groups, single centre. Duration: 16 weeks (preceded by 4 weeks neuroleptic treatment not exceeding chlorpromazine 500 mg/d, thioridazine 500 mg/d, trifluoperazine 30 mg/d, fluphenazine 30 mg/d) + 36 weeks (extended open evaluation)). Analysis: intention‐to‐treat. Country: USA. | |
Participants | Diagnosis: schizophrenia, no further details. N=61. Age: mean ˜ 46 years. Sex: M 37, F 24. Setting: formerly hospitalised (residents of Harbor View House). History: chronic schizophrenia (ill> 2 years or past 3 months hospitalisation with continuous antipsychotic treatment ). Excluded: epilepsy, drug addiction, severe depression, mental retardation, organic brain disease, physical disease, and those receiving heavy sedation. | |
Interventions | 1. Trifluoperazine: range 5‐30 mg/day, mean 17.5 mg. N=20. 2. Pimozide: range 2‐12 mg/day (mean 6.3 mg). N=21. 3. Placebo: N=20. Antiparkinson medication and chloral hydrate if necessary. | |
Outcomes | Global state: (CGI).
Leaving the study early. Unable to use ‐ Mental state: (BPRS ‐ only graphs). Global state: (CGI ‐ no usable data). Social functioning: (Family Rating Form ‐ no usable data; Harbor view house Resident Rating Report ‐ unpublished scale). Adverse events: (no usable data). |
|
Notes | ##High dropout rate(40,1%). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |