Various drugs 1964b.
| Study characteristics | ||
| Methods | Randomisation: randomly assigned. Allocation: procedure not described. Blinding: double‐blind ‐ (apart from previous antipsychotic group) ‐ three different colours which were again changed. Double‐blind condition maintained for patients, ward nurses and psychiatrists. Duration: 7 months. Design: parallel. Location: single‐centre. Setting: inpatient. | |
| Participants | Diagnosis: chronic psychotic patients, treatment resistive in closed wards. No seizures, no antidepressants, no candidates for discharge. N = 88. Gender: 38 men, 40 women. Age: 47 years. History: duration stable‐ 1 year on medication, duration ill‐ n.i., number of previous hospitalisations‐ n.i., age at onset‐ mean 28.1 years, severity of illness‐ mean 11.6 on modified Psychotic Reaction Profile (PRP), baseline antipsychotic dose‐ 39.3mg/ 3 weekly fluphenazine decanoate. |
|
| Interventions | 1. Drug: trifluoperazine (10 mg/day to 90 mg/day), chlorprothixene (50 mg/day to 450 mg/day), same medication (various drugs). Flexible doses. Allowed dose range: n.i.. Mean dose: n.i.. N = 54. 2. Placebo: duration of taper: 0 days. N = 34. Rescue medication: antiparkinson, barbiturate sedation. | |
| Outcomes |
Examined Relapse: clinical judgement. Leaving the study early. Adverse effects. Unable to use/Not included Ward behaviour: unpublished rating scale (no predefined outcome of interest). Urinary excretion (no predefined outcome of interest). |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random, no further details. |
| Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, different colours. |
| Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, different colours. |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, different colours. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts 10 out of 88 is acceptable (11%), although only completers were analysed. |
| Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
| Other bias | Low risk | No evidence for other bias. |