Bai 2006.
Methods | Allocation: random. Blinding: single blind, rater blind. Duration: 12 weeks. Design: parallel. Setting: inpatient, large psychiatric teaching hospital, Taiwan. |
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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. |
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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. |
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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. |
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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. |