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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: single, rater-blinded.
Duration: 6 weeks.
Design: parallel.
Location: single centre.
Participants Diagnosis: (DSM-IV) schizophrenia.
N=56.
Sex: 24 M, 29 F (3 not reported)
Age: 19-46 years (mean clozapine = 31.3 years, mean olanzapine = 29.6 years, mean quetiapine = 30.1 years, mean risperidone = 27.9 years, mean control group = 32.1 years).
History: duration ill mean clozapine = 6.6 years, mean olanzapine = 6.3 years, mean quetiapine = 5.9 years, mean risperidone = 5.6, age at onset: not reported
Interventions
  1. Clozapine: flexible dose. Allowed dose range: not reported. Mean dose: 207.1 mg/day. N = 14.

  2. Olanzapine: flexible dose. Allowed dose range: not reported. Mean dose: 15.7 mg/day. N = 14.

  3. Quetiapine: flexible dose. Allowed dose range: not reported. Mean dose: 535.7 mg/day. N = 14.

  4. Risperidone: flexible dose. Allowed dose range: not reported. Mean dose: 6.7 mg/day. N= 14

Outcomes Leaving the study early: any reason.
Mental State: PANSS total score.
Adverse effects: EPS (use of antiparkinson medication), weight gain (BMI), laboratory (serum leptin, triglyceride levels)
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 Single, rater-blind. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side effects. This can 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 Three subjects in the control groups left the study early (5.4%). Reason for dropout were not assessed, only completer data were presented. But due to the very low rate we do not think that there was a risk of bias
Free of selective reporting? Low risk Probably free of bias. The study focused on serum leptin and triglyceride levels which were adequately described
Free of other bias? Unclear risk Data on the allowed dose range have not been presented. Furthermore, the pre-study treatment was quite heterogeneous as 19 participants had never taken any psy-chotropic drugs while most other participants had a long history of previous treatment