Methods | Allocation: random, no further details. Blindness: single, rater-blinded. Duration: 16 weeks. Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-IV) first episode schizophrenia (n = 84), schizophreniform disorder (n = 19) or schizoaffective disorder (n = 9) (of intent-to-treat population). N = 120. Sex: 78 M, 34 F (of intent-to-treat population). Age: 16-40 years (mean = 23.3 years) (of intent-to-treat population). History: duration ill mean = 2.2 years (of intent-to-treat population), age at onset mean = 20.7 years (of intent-to-treat population). Setting: not reported. |
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Interventions |
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Outcomes | Leaving the study early: inefficacy. Global State. Adverse effects: EPS (parkinsonism, use of antiparkinson medication, Simpson-Angus) , weight gain Unable to use: Leaving the study early: incomplete data. Weight gain: no data. |
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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-blind, rater-blinded. 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 possibly acceptable (28%), but data on leaving the study early were incompletely reported. Eight patients were excluded from the analysis for various reasons. The statistical analysis was based on mixed model approach |
Free of selective reporting? | High risk | Data on the general mental state (PANSS total score) were not presented. The data available for adverse effects were incomplete. Data on weight gain were missing |
Free of other bias? | Unclear risk | Quote: “.. the study was designed to detect differences in our primary analysis at alpha = 0.05 with 80% power based upon 130 subjects, the stability analysis included only 47 subjects and therefore might lack adequate power.” |