Methods | Allocation: random, no further details. Blindness: single (rater-blinded). Duration: 16 weeks (8 weeks observed). Design: parallel. Location: multicentre. |
|
Participants | Diagnosis: (DSM-IV) schizophrenia, PANSS total score of 70 or more, PANSS positive subscore of 4 or more on at least 2 items. N = 75. Sex: M, F: not reported. Age: 18-65 years. History: duration ill not reported, age at onset not reported. Setting: inpatient. |
|
Interventions |
|
|
Outcomes | Leaving the study early: any reason. Mental State: PANSS total score, BPRS hostility cluster score, PANSS positive subscore, PANSS negative subscore). Adverse effects: EPS (BAS, SAS), weight gain. Unable to use: Mental State - PANSS total score, PANSS positive subscore, PANSS negative subscore: no usable data |
|
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random, no further details. |
Allocation concealment? | Unclear risk | No further details. |
Blinding? subjective outcomes |
Unclear risk | Single: rater-blind. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side effects. This can be a problem for blinding |
Blinding? objective outcomes |
Low risk | Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding |
Incomplete outcome data addressed? All outcomes |
Unclear risk | The overall attrition was moderate (18.6%) . The LOCF method was used to account for people leaving the study early. It assumes that a participant who discontinued the study would not have had a change of his condition if he had remained in the study. This assumption can obviously be wrong |
Free of selective reporting? | High risk | Efficacy data (PANSS) were only presented as percentage change without standard deviations, standard errors, P values or ranges. Only interim data after recruitment of half the patients have been presented |
Free of other bias? | High risk | The study was sponsored by the manufacturer of quetiapine. |