Fluphenazine depot 1981.
| Study characteristics | ||
| Methods | Randomisation: randomly assigned. Allocation: procedure not described. Blinding: double‐blind, placebo injection. Duration: 6 weeks. Design: parallel. Location: single‐centre. Setting: outpatient. | |
| Participants | Diagnosis: chronic schizophrenic outpatients (DSM‐III). N = 31. Gender: n.i.. Age: 37 years. History: duration stable‐ 2 years on fluphenazine decanoate 3 weekly, duration ill‐ n.i., number of previous hospitalisations‐ n.i., age at onset‐ 24 years, severity of illness‐ mean GAS (Global Assessment Scale Endicott 1976 by Spitzer & Endicott 1976), baseline antipsychotic dose‐ 39.3 mg/3 weekly fluphenazine decanoate. |
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| Interventions | 1. Drug: fluphenazine decanoate‐ Fixed doses. Allowed dose range: n.i. ‐ same dose as before. Mean dose: n.i.. N = 14. 2. Placebo: duration of taper: 0 days, but all on depot. N = 17. Rescue medication: n.i.. | |
| Outcomes |
Examined Relapse: clinical judgement. Leaving the study early. Service use: number of participants hospitalised. Social functioning: Global Assessment Scale (GAS). Unable to use/Not included Community adjustment: Weissman Social Adjustment scale (no usable data) Depression: SADS (no mean, no SD/no prespecified outcome of interest). Adverse effects: tardive diskinesia (no usable data). |
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| 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, placebo injection. |
| Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, placebo injection. |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, placebo injection. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 out of 30 participants (10%) left the study early which is an acceptable rate, irrespective of the statistical analysis (completer analysis). |
| Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
| Other bias | Low risk | No evidence for other bias. |