Methods | Allocation: random, medication containers according to a pseudo-random computer algorithm. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: single centre. Country: Germany. |
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Participants | Diagnosis: (DSM-IV and ICD-10) schizophrenia, CGI of 4 or more, PANSS of 61 or more. N=52. Age: 18-65 years (mean amisulpride=38.3 years, mean olanzapine=34.3 years). Sex: 23 M, 13 F (of subjects with neuropsychological data, n=36). History: duration ill mean=8.4 years (of subjects with neuropsychological data, n=36), age at onset 27.9 years (of subjects with neuropsychological data, n=36). Setting: inpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global State: CGI. Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore, SANS total score. Cognitive Functioning: Global Cognitive Index total score, trail making test A & B, continuos performance test, seld ordered pointing task, Rey auditory verbal learni g test. Adverse effects: EPS (SAS). |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random, medication containers according to a pseudo-random computer algorithm |
Allocation concealment? | Unclear risk | No further details. |
Blinding? Objective outcomes |
Low risk | Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding |
Blinding? Subjective outcomes |
Unclear risk | Double, no further details. Whether blinding was successful has not been examined, but both compounds differ quite substantially in side-effects. This can be a problem for blinding |
Incomplete outcome data addressed? All outcomes |
High risk | The rate of participants leaving the study early was high (50%). The last-observa-tion-carried-forward 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 and lead to bias in cases of high attrition |
Free of selective reporting? | High risk | Additional treatment with biperiden up to 4mg/day was permitted, but data on use of antiparkinson medication was not available |
Free of other bias? | High risk | The study was sponsored by the manufacturer of olanzapine. |