Methods | Allocation: randomised Blindness: single, rater-blinded. Duration: 8 weeks. |
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Participants | Diagnosis: (CCMD-2) schizophrenia. N=40. Age: mean clozapine=27.6 years, mean risperidone=29 years. Gender: 23 M, 17 F. Setting: inpatient History: duration ill mean clozapine=2.7 years, mean risperidone=3.2 years, age at onset not reported |
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Interventions |
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Outcomes | Mental state: SANS. Adverse effects: extrapyramidal side-effects (akathisia, tremor), sedation, weight gain |
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Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Random, no further details. |
Allocation concealment? | Unclear | No further details. |
Blinding? All outcomes |
Unclear | Single, rater-blind. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side-effects. This can be a problem for blinding Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding. This latter, probably leads a low risk of bias |
Incomplete outcome data addressed? All outcomes |
Yes | No participant left the study early. |
Free of selective reporting? | Yes | No clear evidence for selective reporting. |
Free of other bias? | Unclear | The description of blinding differed between the abstract (double-blind) and the method section (single-blind) |
Scales:
AIMS: Abnormal Involuntary Movement Score
BAS: Barnes Akathisia Scale
BPRS: Brief Psychiatric Rating Scale.
CGI: Clinical Global impression.
ESRS: Extrapyramidal Symptoms Rating Scale
GAF: Global Assessment of Functioning
HAS: Hillside Akathisia Scale
MLDL: Munich Life Dimension List
PANSS: Positive and Negative Syndrome Scale for Schizophrenia
SANS: Scale for the Assessment of Negative Symptoms
SAPS: Scale for the Assessment of Positive Symptoms
SAS: Simpson Angus scale
SFS: Social Functioning scale.
SWN: Subjective Well Being under Neuroleptic Treatment - 38 Items
Diagnostic Tools:
DSM -III-R: Diagnostic and Statistical Manual of Mental Disorders, third edition, revised.
DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, fourth edition.
ICD-9: International Classification of Disease.
CCMD-2: Chinese Classification of Mental Disorders, Second Edition.
CCMD-3: Chinese Classification of Mental Disorders, Third Edition.
Others:
ECG: electrocardiogram
ITT: intent- to- treat.
mg: milligram.
SD: standard deviation.
N: number