C +risperidone 2007.
Methods | Allocation: randomised. Blinding: double‐blind. Duration: 6 weeks. Setting: outpatients. Design: parallel. Country: USA. | |
Participants | Diagnosis: refractory schizophrenia (DSM‐IV). N = 24. Sex: 21 M, 3 F. Age: average 42.3 years (range 27‐55). History: displayed stable, residual psychiatric symptoms; failed at least two previous trials of antipsychotics prior to clozapine and currently treated with clozapine monotherapy for at least 6 months, at a stable dose for at least 8 weeks and with clozapine plasma levels of at 200 ng/mL, unless the clozapine dose necessary to achieve that level was not tolerated. | |
Interventions |
Schedule: risperidone 4 mg/day, clozapine 456 mg/day average (200 mg to 700 mg/day). Subjects received one capsule twice daily for three days, then two capsules twice daily for the rest of the study. |
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Outcomes |
‐ Usable data ‐
‐ Unable to use ‐
‐ Not used in review ‐
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Notes | *The active 6‐week treatment period was preceded by a 2‐week single‐blind placebo lead‐in period to eliminate potential placebo‐responders. ClinicalTrials.gov identifier NCT00289861. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants randomised in blocks of 10. No further details. |
Allocation concealment (selection bias) | Unclear risk | No details provided. |
Blinding (performance bias and detection bias) All outcomes | Low risk | An independent research pharmacy prepared matching capsules that contained either 1 mg risperidone or placebo. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Twopatients in the placebo group and three patients in the risperidone group did not finish the study. |
Selective reporting (reporting bias) | High risk | Not all expected outcomes reported. |
Other bias | Unclear risk | Trial supported by a grant from the Stanley Medical Research Institute. |