Methods | Allocation: randomised - computer-generated randomisation. Blindness: double. Duration: 12 weeks. |
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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) |
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Interventions |
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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). |
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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. |