C +olanzapine 2012.
Methods | Allocation: randomised. Blinding: rater blinded. Duration: 10 weeks. Setting: inpatient. Design: parallel. Country: Japan. | |
Participants | Diagnosis: schizophrenia, schizophreniform disorder, or schizoaffective disorder (DSM IV‐TR). N = 26*. Sex: M 13, F 13. Age: average 39.5 years. History: newly admitted patients with acute schizophrenia who were early non‐responders to risperidone. | |
Interventions |
|
|
Outcomes |
‐ Usable data ‐
‐ Not used in review ‐ Time to treatment discontinuation, blood levels change from baseline (mg/dL); fasting glucose, cholesterol, triglycerides. |
|
Notes | *26/78 participants were early non‐responders to risperidone and were randomised to the two intervention groups. UMIN Clinical Trials Registry: UMIN000003531. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no further details. |
Allocation concealment (selection bias) | Low risk | Opaque, sealed envelopes "We referred to a random number table, with sequentially numbered, opaque, sealed envelopes used to conceal the allocation sequence". |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants and personnel were not blinded. Blind outcome assessment "Rater blinded". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Although 13 participants discontinued treatment, ITT analysis was carried out of all 26 participants. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported. |
Other bias | Low risk | Supported by grants from the Ministry of Health, Welfare, and Labor of the Japanese Government. |