Skip to main content
. 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, computer-generated randomisation.
Blindness: double, no further details.
Duration: 12 weeks.
Design: parallel.
Location: single centre.
Country: not reported (probably USA).
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, BPRS of 35 or more.
N=40.
Age: 10-18 years (mean=15.6 years).
Sex: 21 M, 18 F (of intent-to-treat population).
History: duration ill not reported, age at onset mean clozapine=12.7 years, mean olanzapine=11.7 years (of intent-to-treat population).
Setting: in- and outpatient.
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: open interviews, cholesterol (change from baseline in mg/dl).
EPS (AIMS, Simpson-Angus), sedation, weight change, laboratory (glucose, prolactin, hematology)
Unable to use -
Extrapyramidal symptoms (no data).
Diabetes mellitus (no data).
Hyperglycaemia (no data).
Neutropenia (no data).
Notes One subject was excluded owing to withdrawal of parental consent after randomisation
Risk of bias
Bias Authors’ judgement Support for judgement
Adequate sequence generation? Low risk Random, computer-generated randomisation.
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 the compounds differ quite substantially in side-effects. This can be a problem for blinding
Incomplete outcome data addressed?
All outcomes
Unclear risk Number of participants leaving the study early were moderate (28.2%). The statistical analysis was based on mixed effects model. It is unclear whether this led to bias
Free of selective reporting? High risk Data on adverse effects were incompletely reported.
Free of other bias? Unclear risk The age range of participants included was 10 to 18 years. Sponsorship was neutral