Byerly 2008.
Methods | Allocation: randomised. Blinding: double blind. Duration: 6 weeks. Design: parallel, 1 week cross taper for patients randomised to quetiapine switch. Setting: outpatients; USA. |
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Participants | Diagnosis: DSM‐IV diagnosis of schizophrenia or schizoaffective disorder and risperidone‐associated sexual dysfunction. History: participants with schizoaffective disorder must have received a stable dose of antimanic and/or antidepressant medication for ≥30 days prior to study entry and have experienced stability of mood symptoms for >2 weeks prior to baseline assessments. Written informed consent from patients was obtained. N = 42. Age: 24 to 58 years (mean 42.3 SD 9.6). Sex: 22 men, 20 women. Inclusion criteria: at least 18 years old, moderate sexual dysfunction (ASEX total score ≥ 15), risperidone only antipsychotic ≤ 4 mg/ day (unless history justified higher dose). Participants were excluded if they received a long‐acting injectable antipsychotic within one dosing interval of intended study entry. | |
Interventions | 1. Switching to quetiapine (to 300 mg/day week 1 and 2, 800 mg/day maximum allowable). N = 22. 2. Risperidone continuation (dose continued from pre‐study, N = 20. | |
Outcomes | Leaving the study early Sexual function (subjective assessment): ASEX Sexual function (surrogate assessment): Prolactin levels (ng/mL) Adverse effects: Psychopathology ‐ PANSS |
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Notes | Data were collected over a 3‐year period from May 2002 to October 2005. *Reported in a sub‐sample of participants. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomized", method not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double blind". "Blinding to treatment group was maintained through the use of identical appearing capsules." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | ASEX: “ study utilized self administered questionnaire cards that participants read silently to themselves. The participants then reported only the scale number that corresponded to their experience for each ASEX item” PANSS: collection method not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up reported, but 2 missing observations for ASEX at 6 weeks in the risperidone group; 4 missing observations for ASEX at 6 weeks in the quetiapine group. |
Selective reporting (reporting bias) | High risk | All stated outcomes reported. For ASEX there were missing observations and no reasons given for this. Prolactin levels reported in a sub‐sample of participants. |
Other bias | High risk | Funded by NIMH K‐Award grant # 5 K23 MH064930, the Stanley Medical Research Institute, the Betty Jo Hay Distinguished Chair in Mental Health, Mental Health Connections, a partnership between Dallas County Mental Health and Mental Retardation (MHMR) and the Department of Psychiatry of the University of Texas Southwestern Medical Center, and AstraZeneca LP. (ISS study number DIRUSQUET0186) |