Methods | Allocation: random, computer-generated randomisation. Blindness: double, no further details. Duration: 8 weeks. Design: parallel. Location: multicentre. Country: not reported. |
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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. |
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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-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) |
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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. |