Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 26 weeks. Design: parallel. Location: multicentre. Countries: not reported. |
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Participants | Diagnosis: (DSM-IV) schizophrenia catatonic (n=11), disorganised (n=102) or residual (n=131) (of intent-to-treat population), SANS severity score of 10 or more (excluding the item attention). N=245. Age: mean amisulpride=37.8 years, mean olanzapine (5 mg/day)=38.1 years, mean olanzapine (20 mg/day)=36.4 years, mean placebo=38.2 years. Sex: 167 M, 78 F. History: duration ill mean amisulpride=12.33 years, mean olanzapine (5 mg/day)=10. 08 years, mean olanzapine (20 mg/day)=11.08 years, mean placebo=15.42 years, age at onset not reported. Setting: in- and outpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global State: CGI, relapse, Patient’s global impression. Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore, SANS total score, Psychotic depression Scale. Quality of life: Carpenters QLS total score. Adverse effects: EPS (akathisia, akinesia, parkinsonism, tremor), prolactin associated side effects, sedation, seizures, weight, laboratory (leukopenia) |
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Notes | There is a placebo group (n=35), which is not relevant for this review | |
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? 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 leaving the study early was high (57.6%). The last-observation-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 poses problem given the high attrition |
Free of selective reporting? | High risk | Only those adverse events were reported that occurred with an incidence of at least 10%, therefore rare but important side effects may have been missed by this procedure |
Free of other bias? | High risk | The study was industry sponsored by the manufacturer of olanzapine and one of the authors is employee of that company. A fixed dose regimen was used where it might be difficult to decide which comparator doses are appropriate |