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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, identical capsules.
Duration: 6 weeks.
Design: parallel.
Participants Diagnosis: (DSM-IV) schizophrenia disorganised (n = 9), paranoid (n = 22) or undifferentiated (n = 16) (of intent-to-treat population).
N = 48.
Age: 18-65 years (mean amisulpride = 36.3 years, mean risperidone = 34.1 years).
Sex: 20 M, 27 F (of intent-to-treat population).
Location: multicentre.
Setting: not described.
History: duration ill mean amisulpride = 13.3 years, mean risperidone = 13.4 years, age at onset not reported
Interventions
  1. Amisulpride: flexible dose. Allowed dose range: 400-800 mg/day. Mean dose: 630 mg/day. N = 23.

  2. Risperidone: flexible dose. Allowed dose range: 4-8 mg/day. Mean dose: 6.88 mg/day. N = 25

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State: CGI.
Mental State: PANSS total, BPRS total, PANSS positive subscore, PANSS negative subscore.
General functioning: SOFAS total score.
Adverse effects: open interviews, cardiac effects (QTc interval of > 500 ms), EPS (akathisia, rigor, tremor, use of antiparkinson medication), weight, laboratory (hematology, blood chemistry, urinanalysis)
Unable to use:
ESRS: no data.
Leukopenia: no data.
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, identical capsules. 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
Low risk The rate of participants leaving the study early was below 10% and data on reasons for drop-out were available. The data were analysed on an intent-to-treat basis with the LOCF method. This method is not perfect, but due to the very low attrition the risk of bias was low
Free of selective reporting? High risk Data on the extrapyramidal symptom scale have not been presented. 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.