Wen 2015.
Methods | Allocation: randomised (no detailed information). Blindness: single blind. Duration: 12 weeks. Design: multicentre, parallel. Setting: inpatients and outpatients. Country: China. |
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Participants | Diagnosis: schizophrenia (DSM‐IV). N = 63. Age: mean age 37.1 years. Sex: 43% female. History: treatment with clozapine for > 12 weeks at a dose > 400 mg with no improvement observed, PANSS score ≥ 80 and CGI‐S ≥ 4. |
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Interventions | 1. Clozapine plus ziprasidone: clozapine mean baseline dose = 479 mg/day (SD 56.5), ziprasidone was titrated from 80 mg/day up to 120 mg/day to 160 mg/day, 1 week after ziprasidone was added, the dose of clozapine was reduced accordingly. N = 31. 2. Clozapine plus quetiapine: clozapine mean baseline dose = 481.3 mg/day (SD 51.7), quetiapine was titrated from 200 mg/day up to 400 mg/day to 750 mg/day, 1 week after quetiapine was added, the dose of clozapine was reduced accordingly. N = 32. |
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Outcomes | Clinically significant response: > 50% reduction PANSS. Clinical response: global state (CGI‐S), mental state (PANSS total, PANSS positive, PANSS negative). Adverse effects: rate, agitation, constipation, drowsiness, dry mouth, extrapyramidal adverse effects, headache, insomnia, orthostatic hypotension, tachycardia, vertigo. Leaving the study early. |
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Notes | Chinese language. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation was performed, no detailed information provided. |
Allocation concealment (selection bias) | Unclear risk | No data. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as single blind. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The participants were evaluated by 3 doctors who did not have knowledge about the treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 participants who dropped out were excluded from the analyses of global and mental state outcomes, but included in the analyses of adverse events. Since the attrition rate was < 5%, and reasons were balanced between groups, the study was rated as low risk. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Unclear risk | We could not rule out the potential for other bias. |
General
n: number of participants
SD: standard deviation
Diagnostic tools
CCDM‐2‐R: Chinese Classification of Mental disorders
DSM‐IV: Diagnostic and Statistical Manual of mental disorders, fourth edition
Global effects scales
CGI: Clinical Global Impression
CGI‐S: Clinical Global Impression ‐ Severity
GAF: Global assessment of functioning
Mental state scales
BPRS: Brief Psychiatric Rating Scale
HAMD: Hamilton Depression Scale
PANSS: Positive and Negative Syndrome Scale
SANS: Scale for the Assessment of Negative Symptoms
SAPS: Scale for the Assessment of Positive Symptoms
Adverse effect scales
EPS: Extrapyramidal Symptoms Scale
HAS: Hillside Akathisia Scale
LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale
SAS: Simpson‐Angus Extrapyramidal Symptoms Rating Scale
TESS: Treatment Emergent Symptom Scale
UKU: Udvalg for Kliniske Undersgelser Side Effect Rating Scale