Various drugs 1975.
Study characteristics | ||
Methods | Randomisation: random, in blocks of eight, stratified for age, duration ill and time since last admission. Allocation: procedure not described. Blinding: double‐blind, identical capsules, each participant had an individual stock bottle. Duration: 24 weeks. Design: parallel. Location: single‐centre. Setting: outpatient. | |
Participants | Diagnosis: chronic schizophrenia (clinical diagnosis), 22 undifferentiated, 7 paranoid, 1 schizoaffective, no severe other psychiatric or somatic illnesses, no severely ill participants. N = 40. Gender: 40 women. Age: mean 42.8 years (range 24 to 60). History: duration stable‐ maintained on medication in an outpatient status for at least 3 months, "relatively stable state of health”, duration ill‐ mean 11.6 years, number of previous hospitalisations‐ mean 6.1, age at onset ‐ NI, severity of illness‐ mean CGI severity score 2.94, baseline antipsychotic dose‐ n.i.. |
|
Interventions | 1. Drug: pimozide.* Flexible dose. Allowed dose range: 2 mg/day to 20 mg/day. Mean dose: 5.3 mg/day. N = 15. 2. Drug: thioridazine.* Flexible dose. Allowed dose range: 75 mg/day to 750 mg/day. Mean dose: 189 mg/day. N = 15. 3. Placebo: duration of taper: 0 days. N = 10. Rescue medication: antiparkinson medication, bedside sedation. |
|
Outcomes |
Examined Relapse (worsening of global state). Leaving the study early. Global state: number of participants improved (CGI based). Global state ‐ number of participants in remission (CGI based) Adverse effects: binary outcomes ‐ open interview. Unable to use/Not included Mental state: BPRS (no SD/no prespecified outcome of interest). Functioning: Katz Lyerly Scale of Social Adjustment, Patient Rating Form, Family Rating Form (no data available ) Physiological measures: biological parameters (temperature, mean weight, pulse, blood pressure, all no data/all no prespecified outcomes of interest), laboratory (blood count, urine analysis, liver enzymes, blood sugar, protein bound iodine, all no prespecified outcomes of interest). |
|
Notes | * The results of pimozide and thioridazine were combined in the analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random, in blocks of eight, stratified for age, duration ill and time since last admission. |
Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, identical capsules, each participant had an individual stock bottle. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, identical capsules, each participant had an individual stock bottle. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, identical capsules, each participant had an individual stock bottle. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Overall 36% left the study early. The specific reasons why the participants dropped out were not indicated by group. |
Selective reporting (reporting bias) | Low risk | No clear source for selective reporting. |
Other bias | Low risk | No clear other sources of bias. |