Heisterberg 2007.
Methods | Allocation: randomised.
Blindness: double.
Duration: 6 weeks. Setting: no information available. Design: multicentre, parallel groups. |
|
Participants | Diagnosis: schizophrenia as per DSM‐IV‐TR. N = 599. Age: 18‐69 years. Sex: male and female. History: having an acute exacerbation of schizophrenia. Inclusion criteria: baseline PANSS score of 70 to 120 and CGI score of ≥ 4. Exclusion criteria: no information available. | |
Interventions | 1. Risperidone: dose 6 mg/day, N = 154. 2. Placebo: N = 149. 3. Bifeprunox: N = 296. | |
Outcomes | Adverse events: lipid parameters*, EPS. Leaving the study early. Unable to use: Adverse effects: weight change (no SD reported). |
|
Notes | Study attrition was 60% at the end of 6 weeks ‐‐ no data included in efficacy analysis. *We reported this data as the paper used LOCF to account for missing values. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no further information. Quote: "...patients with acutely exacerbated schizophrenia were randomly assigned to..." |
Allocation concealment (selection bias) | Unclear risk | No information available. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis done. |
Selective reporting (reporting bias) | Unclear risk | Outcomes listed in the methods were reported. |
Other bias | Low risk | None obvious. |