Fluphenazine 1980.
Study characteristics | ||
Methods | Randomisation: random 2:1, no further details. Allocation: procedure not described. Blinding: double‐blind, no further details. Duration: 15 weeks. Design: parallel. Location: four hospitals. Setting: outpatient. | |
Participants | Diagnosis: schizophrenia (DSM‐II). N = 67. Gender: 34 men, 33 women. Age: mean 31.7 years. History: duration stable‐ continuously and successfully treated for one year, duration ill‐ n.i., number of previous hospitalisations‐ n.i., age at onset‐ n.i., severity of illness‐ n.i., baseline antipsychotic dose‐ oral fluphenazine mean 24.4 mg/day, depot fluphenazine 30.9 mg/3 weeks. |
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Interventions | 1. Drug: oral fluphenazine (n = 6) or depot fluphenazine (n = 11). Fixed/flexible dose: unclear. Allowed dose range: unclear. Mean dose: unclear. N = 17. 2. Placebo: duration of taper: 0 days. N = 50. Rescue medication: n.i., but antipsychotics were probably not allowed. |
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Outcomes |
Examined Relapse: rehospitalisation or deterioration in clinical condition which could not be managed within protocol limits (e.g. increased psychological support or adjustment of dosage). Adverse effects: tardive dyskinesia (AIMS). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random 2:1, 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, no further details. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, no further details. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, no further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is unclear whether there were participants who left the study early. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | Low risk | No clear evidence for other bias. |