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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Mar 17;(3):CD006654. doi: 10.1002/14651858.CD006654.pub2
Methods Allocation: random, no further details.
Blindness: double, no further details.
Duration: 8 weeks.
Design: parallel.
Location: multicentre.
Countries: France, Italy, Tunisia.
Participants Diagnosis: (DSM-IV) schizophrenia and comorbid depression, disorganised (n=26), paranoid (n=32), residual (n=4) or undifferentiated (n=23) .
N=85.
Age: 18-65 years (mean=34 years).
Sex: 54 M, 31 F.
History: duration ill not reported, age at onset not reported.
Setting: in- and outpatient.
Interventions
  1. Amisulpride: flexible dose. Allowed dose range: 200-600 mg/day. Mean dose: 471 mg/day. N=45.

  2. Olanzapine: flexible dose. Allowed dose range: 5-15 mg/day. Mean dose: 11.4 mg/day. N=40

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State.
Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore, Calgary depression scale.
Adverse effects: open interviews, cardiac effects (QTc), EPS (tremor), weight, laboratory (cholesterol, glucose)
Unable to use -
Tremor: (no usable 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?
Objective outcomes
Low risk Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding
Blinding?
Subjective outcomes
Unclear risk Double, no further details. Whether blinding was successful has not been examined, but both compounds differ quite substantially in side-effects. This can be a problem for blinding
Incomplete outcome data addressed?
All outcomes
Low risk The rate of participants leaving the study early was 16.5% and reasons for leaving the study early were provided. The analysis was based on the last-observation carried forward method with two people being excluded due to no exploitable outcome data. In addition there was a per protocol population which excluded subjects with a major protocol deviation. As two different methods with similar results were applied and as the overall attrition was low we do not think that there was a bias
Free of selective reporting? High risk Data on extrapyramidal symptoms were not provided.
Free of other bias? High risk The study was sponsored by the manufacturer of amisulpride.
Additionally there was a relatively high number of subjects (18) with major protocol deviations