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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jan 19;(1):CD006626. doi: 10.1002/14651858.CD006626.pub2
Methods Allocation: random, no further details.
Blindness: double, no further details.
Duration: 26 weeks.
Design: parallel.
Location: multicentre.
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
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 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
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.