Potkin 2007.
Methods | Allocation: randomised.
Blindness: double.
Duration: 6 weeks. Setting: 21 sites in USA. Design: parallel. |
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Participants | Diagnosis: schizophrenia. N = 180. Age: 18 to 65 years. Sex: not reported. History: participants with acute exacerbation were included in the trial. Inclusion criteria: baseline PANSS score > 60. Exclusion criteria: recent history of suicide attempt or serious suicide thoughts, neurological disorders other than TD or EPS, psychoactive substance dependence or history of drug or alcohol abuse within 1 month. | |
Interventions | 1. Risperidone: dose 6 mg/day, N = 59. 2. Placebo: N = 62. 3. Asenapine: dose 10 mg/day, N = 59. | |
Outcomes | Leaving the study early. Adverse effects. Unable to use: Global state: CGI (> 50% loss to follow‐up, thus data was not reported). Mental state: PANSS (> 50% loss to follow‐up, thus data was not reported). Function: battery of neurocognitive test (no SD reported), WCST (no data reported). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no further information. |
Allocation concealment (selection bias) | Unclear risk | No information available. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double dummy placebo design was employed to maintain blinding. Quote: "this double‐blind, double‐dummy, 3‐arm, fixed‐dose..." (p1493). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT for efficacy data and LOCF for safety data. |
Selective reporting (reporting bias) | Low risk | All outcomes measured were reported. |
Other bias | High risk | Funded by Organon USA Inc and Pfizer Inc. |