Methods | Allocation: random, computer-generated randomisation. Blindness: double, no further details. Duration: 12 weeks. Design: parallel. Location: single centre. Country: not reported (probably USA). |
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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, 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. |
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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: 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). |
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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 |