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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, computer-generated randomisation.
Blindness: double, no further details.
Duration: 8 weeks.
Design: parallel.
Location: multicentre.
Country: not reported.
Participants Diagnosis: Children and adolescents with (K-SADS-P or DSM-IV) schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, major depression with psychotic features or bipolar affective disorder with psychotic features, schizophrenia spectrum (n=26), affective disorders (n=24) subjects selected because of prominent positive psychotic symptoms (of intent-to-treat population).
N=51.
Age: 8-19 years (mean=14.8 years).
Sex: 30 M, 21 F.
History: duration ill not reported, age at onset mean=12.4 years.
Setting: in- and outpatient.
Interventions
  1. Haloperidol : flexible dose. Allowed dose range: 1-8 mg/day. Mean dose: 5.0 mg/day. N=15.

  2. Olanzapine: flexible dose. Allowed dose range: 2.5-20 mg/day. Mean dose: 12.3 mg/day. N=16.

  3. Risperidone: flexible dose. Allowed dose range: 0.5-6 mg/day. Mean dose: 4.0 mg/day. N=20

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State: CGI.
Mental State: BPRS-C total score, CPRS.
Adverse effects: open interviews, cardiac effects (QTc, vital signs), EPS (akathisia, use of antiparkinson medication, Simpson-Angus), prolactin associated side effects (amenorrhoea, galactorrhoea, gynaecomastia), sedation, gastrointestinal malfunction, weight (BMI), laboratory (glucose, prolactin)
Notes
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
High risk The attrition rate was rather high (33. 3%). The last-observation-carried-forward method was used to account for people leaving the study early. It assumes that a participant who discontinued the study would not have had a change of his condition if he had remained in the study. This assumption can obviously be wrong. It is unclear whether this led to bias
Free of selective reporting? Low risk No evidence for selective reporting.
Free of other bias? High risk Quote: “.…this ..study has a number of limitations including limited sample size, differences in the diagnosis of participants, use of co-comitant medication, variations in age and perpetual status”.
Comment: Probably not free of bias.