Methods | Allocation: random, computer-generated randomisation. Blindness: double, identical capsules. Duration: 24 weeks. Design: parallel. Location: multicentre. Countries: Belgium, Czech Republic, Denmark, France, Hungary, Morocco, Portugal, UK, Switzerland, Tunisia |
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Participants | Diagnosis: (DSM-IV) schizophrenia disorganised (n=33), paranoid (n=260) or undifferentiated (n=76) or schizophreniform disorder (n=8), dominant positive symptoms, BPRS of 36 or more, PANSS positive score higher than PANSS negative score. N=377. Age: 18-65 years (mean amisulpride=38.2 years, mean olanzapine=37.4 years). Sex: 245 M, 132 F. History: duration ill mean amisulpride=9.56 years, mean olanzapine=8.12 years, age at onset, not described. 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. Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore, Depression MADRS. General Functioning: SOFAS total score. Quality of life: QLS total score. Adverse effects: open interviews, cardiac effects (ECG), death (natural causes, suicide) EPS (akathisia, dystonia, parkinsonism, use of antiparkinson medication, AIMS, Simpson-Angus), glucose, sedation, weight Unable to use - Amenorrhoea (no data). |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Low risk | Random, computer-generated randomisation. |
Allocation concealment? | Low risk | Computer generated randomisation list was prepared and kept outside the study centre. Quote: Patient numbers were assigned in strict chronological order in each centre |
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, identical capsules. Quote: “to permit dose adjustment whilst maintaining the double-blind, blister packs corresponding to a low and a high dosage were provided”. 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 (35.8%). 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. It is unclear whether this led to bias |
Free of selective reporting? | High risk | Only those adverse events that occurred in at least 5% of the participants were reported. This procedure can miss rare, but important adverse events |
Free of other bias? | High risk | The study was sponsored by the manufacturer of amisulpride. |