Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 26 weeks. Design: parallel. Location: multicentre. |
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Participants | Diagnosis: (DSM-IV) chronic schizophrenia disorganised (n = 37), paranoid (n = 227), residual (n = 19) or undifferentiated (n = 27), PANSS between 60 and 120, recent worsening of symptoms. N = 310. Age: 18-65 years (mean = 38.4 years). Sex: 170 M, 140 F. Setting: in- and outpatient. History: duration ill mean = 11.8 years, age at onset not described |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global State: CGI, relapse. Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore, SANS total score. General functioning: SOFAS total score. Adverse effects: open interviews, death (natural causes, suicide), EPS (akathisia, hyperkinesia, parkinsonism, tremor, use of antiparkinson medication, AIMS, SAS), prolactin associated side effects (amenorrhea, galactorrhea, sexual dysfunction), sedation, seizures, weight |
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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 | Double, no further details. Whether blinding was successful has not been examined, but both compounds differ in side effects. This may 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 |
High risk | The rate of participants leaving the study early was high (40%). 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 | 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. |