Quetiapine 2010.
Study characteristics | ||
Methods | Randomisation: sequence by computer, fixed block size of four without stratification. Allocation: AstraZeneca prepared individually numbered sets of study drugs, packed them according to the randomisation sequence and then shipped them to the study team in numbered but apparently identical sets. Blinding: identical capsules, "investigators, patients and all research staff were blind to the study drugs and the block size". Duration: 1 year. Design: parallel. Location: single‐centre (all in Early Assessment Service for Young People with Psychosis (EASY) in Hong Kong). Setting: outpatient. | |
Participants | Diagnosis: schizophrenia and related psychoses (DSM‐IV), all first episode, all well remitted, all had remained well on maintenance medication for 1 year. N = 178. Gender: 80 men, 98 women. Age: 24.2 years. History: duration stable‐ 1 year, duration ill‐ 2.3 years, number of previous hospitalisations‐ 0 (first episode), age at onset‐ 21.9 years, severity of illness‐ mean PANSS 36, baseline antipsychotic dose‐ 153 mg/day chlorpromazine equivalents. |
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Interventions | 1. Drug: quetiapine. Fixed dose of 400 mg/day. N = 89. 2. Placebo: duration of taper (days): 35. N = 89. Rescue medication: antipsychotics not allowed. |
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Outcomes |
Examined Relapse: (i) an increase in at least one of the following PANSS psychotic symptom items to a threshold score (delusion, hallucinatory behaviour, conceptual disorganisation, unusual thought content, suspiciousness; (ii) Clinical Global Impression Severity of Illness 3 or above and (iii) CGI change 5 or above). Leaving the study early. Rehospitalisation. Suicide attempts. Adverse effects: akathisia, tardive dyskinesia, tremor, sedation, weight gain. Open employment status. |
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Notes | Supported by investigator initiated trial award from AstraZeneca. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence by computer, fixed block size of four without stratification. |
Allocation concealment (selection bias) | Low risk | AstraZeneca prepared individually numbered sets of study drugs, packed them according to the randomisation sequence and then shipped them to the study team in numbered but apparently identical capsules. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Identical capsules, "investigators, patients and all research staff were blind to the study drugs and the block size". |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Identical capsules, "investigators, patients and all research staff were blind to the study drugs and the block size". |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Identical capsules, "investigators, patients and all research staff were blind to the study drugs and the block size". |
Incomplete outcome data (attrition bias) All outcomes | High risk | 72% of the participants left the study early. As most participants dropped out after relapse this outcome was not affected, but it is a source of bias for other outcomes. Survival analysis for the primary outcome relapse. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | Low risk | No clear other bias. |