Fluphenazine depot 1968.
Study characteristics | ||
Methods | Randomisation: randomly assigned, no further details. Allocation: procedure not described. Blinding: double‐blind, placebo treated participants received injections of sesame oil in a similar amount. Duration: 12 weeks. Design: parallel. Location: single‐centre. Setting: outpatient. | |
Participants | Diagnosis: chronic schizophrenia (clinical diagnosis), 12 paranoid, 3 hebephrenic, 2 catatonic, 1 simple, 6 chronic undifferentiated, on antipsychotic medication for a mean duration of 2 years. N = 24. Gender: 4 men, 20 women. Age: mean 36 years. History: duration stable‐ minimum six weeks stable on oral fluphenazine, duration ill‐ mean 12.4 years, number of previous hospitalisations‐ n.i., age at onset‐ mean 23.6 years, severity of illness‐ n.i., baseline antipsychotic dose‐ mean 28.5 mg fluphenazine decanoate biweekly. |
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Interventions | 1. Drug: fluphenazine decanoate ‐ Flexible doses. Allowed dose range: 12.5 to 75/mg biweekly. Mean dose: n.i.. N = 13 2. Placebo: sesame oil injections. Duration of taper: 0 days. N = 11. Rescue medication: antiparkinson medication, additional fluphenazine decanoate ‐ but this was considered to be a relapse. |
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Outcomes |
Examined Relapse: clinical deterioration requiring additional antipsychotic drug treatment. Leaving study early. Service use: number of participants hospitalised. Adverse effects (at least one movement disorder). Unable to use / Not included: Global state: 7‐point scale of severity (no usable data for the two study arms ). Mental state: scale published by the authors (no SD/no predefined outcome of interest). Adverse effects: scale published by the authors (no numbers). Physiological measures: ECG, EEG, laboratory (all no data/no predefined outcomes of interest). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned, 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 treated participants received injections of sesame oil in a similar amount. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, placebo treated participants received injections of sesame oil in a similar amount. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, placebo treated participants received injections of sesame oil in a similar amount. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participant left the study early. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | High risk | In case of deterioration the participants received additional antipsychotic drugs. This is a problem for the analysis of side effects. |