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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Nov 10;(11):CD006633. doi: 10.1002/14651858.CD006633.pub2
Methods Allocation: randomised - computer-generated randomisation.
Blindness: double.
Duration: 12 weeks.
Participants Diagnosis: children and adolescents with (DSM-IV) schizophrenia (N=25) or schizoaffective disorder (N=14) (of intent-to-treat population), resistant to, or intolerant of, at least two antipsychotic treatments.
N=40.
Age: 10-18 years (mean=15.6 years).
Gender: 21 M, 18 F (of intent-to-treat population).
Setting: in- and outpatient.
History: duration ill not reported, age at onset mean clozapine=12.7 years, mean olan-zapine=11.7 years (of intent-to-treat population)
Interventions
  1. Clozapine: flexible dose. Allowed dose range: 50-700 mg/day. Mean dose: 403.1 mg/day. N=18 (of intent-to-treat population).

  2. Olanzapine: flexible dose. Allowed dose range: 10-30 mg/day. Mean dose: 26.2 mg/day. N=21 (of intent-to-treat population)

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global state: CGI.
Mental state: BPRS total score, SANS total score.
Adverse effects:at least one adverse effect, extrapyramidal side effects (AIMS, SAS), glucose (change from baseline in mg/dl), lipids (change on cholesterol from baseline in mg/dl), prolactin associated side effects (change from baseline in ng/ml - ofmen only, change from baseline in ng/ ml - of women only), sedation, weight change
Unable to use:
Extrapyramidal symptoms (no data)
Diabetes mellitus (no data).
Hyperglycemia (no data).
Neutropenia (no data).
Notes One person was excluded owing to withdrawal of parental consent after randomisation
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Quote: “…medication were assigned to their groups by research pharmacist with a computer-generated randomisation schedule.”
Allocation concealment? No Probably not done.
Blinding?
All outcomes
Yes Quote: “medication was administered under double-blind condition”. The success of blinding was not evaluated
Incomplete outcome data addressed?
All outcomes
No 4/19 missing from clozapine and 7/21 missing from olanzapine
Quote:“…analyses were performed on the intent-to-treat population”
Comment: ITT considered all patients who received at least one dose of study medication
Free of selective reporting? No Side-effects: Study reported only the participants who gained >7% of their baseline body weight
Free of other bias? Yes Review authors have not found other sources of bias.