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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Nov 10;(11):CD006633. doi: 10.1002/14651858.CD006633.pub2
Methods Allocation: randomised
Blindness: single, rater-blinded.
Duration: 8 weeks.
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
Interventions
  1. Clozapine: fixed and flexible dose (first two weeks). Allowed dose range: 25-300 mg/day (first two weeks), then 300 mg/day fixed. Mean dose: not reported. N=20.

  2. Risperidone: Fixed and flexible dose (first two weeks). Allowed dose range: 1-6 mg/day (first two weeks), then 6 mg/day fixed. Mean dose: not reported. N=20

Outcomes Mental state: SANS.
Adverse effects: extrapyramidal side-effects (akathisia, tremor), sedation, weight gain
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