Sechter 2002.
Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 26 weeks. Design: parallel. | |
Participants | Diagnosis: schizophrenia (DSM‐IV) ‐ disorganised (n=37), paranoid (n=227), residual (n=19) or undifferentiated (n=27). N=310. Age: 18‐65 years, mean=38.4 years. Sex: 170M, 140F. Location: multicentre. Setting: inpatient and outpatient. History: PANSS score between 60 and 120, chronically ill with recent worsening of symptoms, mean duration illness=11.8 years. Excluded: predominant negative symptoms, aberrant medical condition. | |
Interventions | 1. Amisulpride: flexible dose. Allowed dose range: 400‐1000 mg/day. Mean dose: 683 mg/day. N=152. 2. Risperidone: flexible dose. Allowed dose range: 4‐10 mg/day. Mean dose: 6.92 mg/day. N=158. |
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Outcomes | Global State: CGI, relapse. Leaving the study early: any reason, adverse events, inefficacy. 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 (amenorrhoea, galactorrhoea, sexual dysfunction), sedation, seizures, weight. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random, no further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double, no further details. Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding. |
Blinding (performance bias and detection bias) 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. |
Incomplete outcome data (attrition bias) | High risk | The rate of participants leaving the study early was considerable (40%). 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 often be wrong. |
Selective reporting (reporting bias) | High risk | Adverse effects had to occur with an incidence of at least 5% to be reported. Rare but important side effects may have been missed by this procedure. |
Other bias | High risk | The study was sponsored by the manufacturer of amisulpride. |