Glazer 1990a.
Methods | Allocation: "randomly assigned", not described
Blindness: double, "identical capsules"
Design: parallel groups Setting: outpatients, USA Duration: 2 weeks |
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Participants | Diagnosis: schizophrenia or schizoaffective disorder with TD (operational criteria) and criterion for withdrawal‐exacerbated TD N = 18 Age: mean 47 years Sex: 55% women History: duration of TD at least 3 months; "Patients had been receiving at least a year of continuous treatment with antipsychotics other than molindone or haloperidol"; "After a week on one of these two medications at pre‐established doses equivalent to that of the pre‐study neuroleptic" | |
Interventions | Antipsychotic medications were tapered over a 7‐10 d period and then withdrawn, with single‐blind substitution of placebo for 7‐14 d. Study medication was administered when there was a demonstrable increase in involuntary movements. 1. Molindone: dose 75 mg (mean) during the first week (100% of pre‐trial dose equivalent) and 145 mg (mean) (200% of pre‐trial dose equivalent) during the second week. N = 9 2. Haloperidol: dose 19.3 mg (mean) (100% of pre‐trial dose equivalent) during the first week and 34.3 mg (mean) (200% of pre‐trial dose equivalent) during the second week. N = 9 Concomitant medications: psychoactive medications including antiparkinsonism agents, within 6 months before study entry were not allowed |
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Outcomes | Clinical improvement: AIMS
Leaving the study early Unable to use ‐ Mental state: BPRS Websters Parkinson Rating Scale: no usable data |
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Notes | Sponsorship source: supported in part by a grant from E.I. DuPont Pharmaceutical Company and National Institute of Mental Health Grant | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned to receive either molindone or haloperidol in a double‐blind fashion", further details not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "double blind" "Medication was supplied in identical‐appearing red capsules containing 25 mg and 5 mg, respectively, of molindone and haloperidol" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "double‐blind". Details of blinding of outcome assessment not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants completed the trial |
Selective reporting (reporting bias) | Unclear risk | Unclear if psychiatric symptoms, dyskinetic movements and parkinsonism measured by BPRS and Webster Parkinsonism Rating Scale were defined as outcomes. Only AIMS results were reported. |
Other bias | High risk | The two groups were comparable except for a greater past hospitalisation duration in the molindone as compared with haloperidol‐treated group |