Methods | Allocation: random, no further details. Blindness: double, no further details. Duration: 52 weeks. Design: parallel. Location: multicentre. Country: not reported. |
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Participants | Diagnosis: (DSM-IV) schizophrenia (n=231), schizophreniform disorder (n=115) or schizoaffective disorder (n=54), first episode, psychotic symptoms for 1 month to 5 years, PANSS psychosis and CGI-S score of 4 or more. N=400. Age: 16-40 years (mean=24.5 years). Sex: 292 M, 108 F. History: duration ill mean=1.08 years, age at onset 23.5 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: PANSS total, PANSS positive subscore, PANSS negative subscore, depression Calgary depression scale. Adverse effects: open interviews, death (suicide attempt, suicide, EPS (akathisia, akinesia, use of antiparkinson medication, laboratory (cholesterol, fasting glucose, prolactin) , prolactin associated side effects (amenorrhoea, galactorrhoea, gynaecomastia, sexual dysfunction), sedation, insomnia, dry mouth, orthostatic faintness, constipation, sialorrhoea, skin rash, gynaecomastia, urinary hesitancy, incontinence, weight gain (BMI, waist circumference) |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random, no further details. |
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 high (70.3.%). Analysis was based on mixed effects model and secondary on last-observation-carried forward and observed cases. It is unclear whether any statistical method can account for such a high drop-out rate |
Free of selective reporting? | High risk | Adverse events were presented only in case of moderate or worse severity |
Free of other bias? | High risk | The study was sponsored by the manufacturer of quetiapine. |