Emsley 2004.
Methods | Allocation: "randomly assigned", not described
Blindness: investigators blinded
Design: parallel group Setting: inpatients and outpatients, South Africa Duration: 50 weeks |
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Participants | Diagnosis: schizophrenia (DSM IV), TD (Schooler and Kane criteria) N = 45 Age: 49.2 (SD 14.5) years, range 18‐65 years Sex: 16 men and 29 women History: duration of TD not reported; at least 3 months' antipsychotic exposure; patients with established psychiatric disorder who did not receive clozapine | |
Interventions | After an initial screening visit, subjects were tapered from all psychotropic medication over a 2‐week period. 1. Quetiapine: dose 100 mg/d increased to 400 mg/d. N = 22 2. Haloperidol: dose 5 mg/d increased to 10 mg/d. N = 23 Concomitant medications allowed were benzodiazepines for agitation or insomnia and anticholinergic agents in the event of treatment‐emergent or worsening EPS. Medications not allowed were other antipsychotics or other medication known to improve or exacerbate movement disorders. |
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Outcomes | TD symptoms: no clinical improvement
Leaving the study early General mental health PANSS Unable to use ‐ Adverse effects: ESRS, EPS (no usable data) Global assessment: CGI. (data in graphs, no variability) |
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Notes | Sponsorship source: supported in part by the Medical Research Council of South Africa, Cape Town, and the University of Stellenbosch. Trial medication and monitoring of the study were provided by AstraZeneca, Wilmington, Del. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Subjects were then randomly assigned", further details not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "investigator‐blinded", further blinding details not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "investigator‐blinded", further blinding details not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 43% dropouts (including the 2 participants excluded in the early stages). 10/22 (45%) quetiapine and 8/23 (35%) haloperidol participants dropped out. |
Selective reporting (reporting bias) | High risk | Adverse effects: extrapyramidal symptoms (other than dyskinesia) not fully reported |
Other bias | Low risk | The study seems to be free of other sources of bias. Baseline characteristics were balanced in the compared groups. |