Bai 2003.
Methods | Allocation: "randomly assigned", not described
Blindness: "double blind", partially described
Design: parallel groups
Setting: inpatients, Taiwan Duration: 12 weeks |
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Participants | Diagnosis: schizophrenia with persistent severe TD (DSM IV, Kane criteria)
N = 49 randomised, 42 completed
Age: 50.2 (SD 9.7) years
Sex: 28 men and 14 female History: maintenance on conventional antipsychotics for > 1 year with an equivalent dosage of < 200 mg/d of chlorpromazine; duration of TD not reported |
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Interventions | After a 4‐week washout period with all original conventional antipsychotics discontinued: 1. Risperidone: started at 2 mg/d and increased, with a 2‐mg increase every 2 weeks, to 6 mg/d over 6 weeks; then maintenance dose 6 mg/d for 12 weeks. N = 22 2. Placebo: placebo for 12 weeks. N = 20 Concomitant medication included benzodiazepines (86%‐90%) and antiparkinsonism drugs (50%‐86%) |
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Outcomes | TD symptoms: AIMS Adverse effects: extrapyramidal symptoms (parkinsonism) (ESRS) Adverse effects: dystonia (ESRS) TD symptoms: clinical efficacy (decrease in AIMS of 3 or 4 = responder) BPRS |
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Notes | Sponsorship source: supported by Janssen‐Cilag Taiwan, Johnson & Johnson Taiwan Ltd | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "subjects were randomly assigned to the risperidone or placebo groups", 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" "A placebo with an identical appearance to the risperidone dose was prescribed for the placebo group using the same dose schedule." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The TD condition was evaluated blindly by a psychiatrist with the Abnormal Involuntary Movement Scale (AIMS) every 2 weeks" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Forty‐two patients completed the 12‐week study and 7 subjects withdrew. Four subjects dropped out due to psychotic symptom exacerbation (2 subjects during the washout period: 1 subject in the placebo group and 1 subject in the risperidone group). Another 3 subjects withdrew due to a medical condition (infectious disease, heart condition, and lung carcinoma)." |
Selective reporting (reporting bias) | Unclear risk | Unclear if all pre‐defined outcomes were reported. A protocol is not available for verification. |
Other bias | Low risk | The study seems to be free of other sources of bias. |