Lucius 1976.
Methods | Allocation: matched pairs were randomised. Allocation procedure conducted independently by hospital pharmacist and not reported to trialists.
Blindness: double, unclear.
Duration: 5 weeks, preceded by pre‐entry period 1 week.
Design: cross‐over. Setting: long‐term inpatients. Raters: two independent raters under standardised conditions. |
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Participants | Diagnosis: schizophrenia (8), bipolar (1), cerebral sclerosis (1) + TD (diagnosed by 3 physicians using criteria). History: mean duration antipsychotic drugs ˜12 years (range 2‐19), mean CPE dose ˜177 mg/day (100 mg to 225 mg). N = 20 (please see notes). Sex: 2 M, 8 F. Age: mean 62 years (28‐75). | |
Interventions | 1. Deanol: dose gradually increased to 1500 mg/day. N = 5. 2. Placebo. N = 5. Antiparkinsonians ceased 8 days before trial. | |
Outcomes | TD symptoms.
Mental state.
Adverse effects.
Leaving study early. Unable to use ‐ TD symptom scores: local scale (not validated). |
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Notes | Original study N = 20. Due to information about toxic effects of clozapine in July 1975, antipsychotic medication abruptly changed. In dissertation, detailed individual patient data supplied. Data extracted for 10 participants whose antipsychotic medication was stable during study. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised" No further details. |
Allocation concealment (selection bias) | Low risk | "pharmacy‐controlled allocation, identical sequentially number drug containers". |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Identical capsules planned, but apparently differences in form and taste. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "two independent raters under standardised conditions". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts with reasons reported, but unclear in which treatment phase of cross‐over study. |
Selective reporting (reporting bias) | Unclear risk | No protocol available and the study outcomes are unclear if all were reported. |
Other bias | Unclear risk | Unclear the cross‐over phases. |