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. 2016 Apr 14;2016(4):CD004161. doi: 10.1002/14651858.CD004161.pub2

Bai 2006.

Methods Allocation: random.
Blinding: single blind, rater blind.
Duration: 12 weeks.
Design: parallel.
Setting: inpatient, large psychiatric teaching hospital, Taiwan.
Participants Diagnosis: schizophrenia (DSM‐IV).
Age: 18‐65 years.
N = 50.
Sex: 25 M and 25 F.
History: symptomatically stable defined as PANSS total < 80, CGI‐no change in score between screening and baseline, previous treatment with oral risperidone for > 3 months.
Included: 'good health' based on physical examination, medical history and blood biochemistry and haematology.
Exclusion: History of NMS or organic CNS disorder; current seizure disorder; current risk of violent behaviour against others; current suicidal ideas or suicidal ideas in the last 6 months.
Consent and ethics: study performed in accordance with the Declaration of Helsinki and approved by Ethics Review Committee. All participants provided written informed consent before starting the study.
Interventions 1. Risperidone depot: 25 mg, 37.5 mg or 50 mg once every 2 weeks, n = 25.
2. Risperidone oral: mean 3.8 +/‐ 1.6 mg/day, n = 25.
Outcomes Quality of life (SF‐36).
Adverse events (recorded spontaneously); AIMS; BARS; SAS; UKU; movement disorder.
Mental state: PANSS.
Global state: CGI‐S, GAF.
Leaving study early.
Unable to use ‐
Satisfaction with treatment ‐ non‐peer reviewed scale.
Pain at injection site (visual analogue scale) ‐ no SD reported.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "this trial was a randomized, parallel‐group, rater‐blind study of 52 weeks duration." No information on how randomisation was achieved.
Allocation concealment (selection bias) Unclear risk No information.
Blinding (performance bias and detection bias) 
 All outcomes High risk Implied to be an open‐label study. Not explicit, but implied open‐label with regard to participants and study drug administrators. Detection: "rater blind", but no information on how the blinding was maintained.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk N = 49 participants completed the study (98%).
Selective reporting (reporting bias) Low risk All outcomes listed in methods appear to be reported.
Other bias High risk Funding: supported by Jassen‐Cilag Taiwan, Johnson & Johnson co.