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. 2010 Jan 20;2010(1):CD006624. doi: 10.1002/14651858.CD006624.pub2

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.
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.