Covell 2012.
Methods | Allocation: random. Blinding: open‐label, blinded clinical raters. Duration: 6 months (+ 6 months naturalistic follow‐up). Design: parallel. Setting: National Institute of Mental Health Schizophrenia Trials Network and five sites in Conneticut's public mental health system, USA. |
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Participants | Diagnosis: schizophrenia (DSM‐IV). Age: ≥18 years, mean age 48 yrs (risperidone depot: 48.5 ± 12.2; haloperidol/fluphenazine depot: 47.3 ± 9.1). N = 62. Sex: 44 M (22 in each group), 18 F. History: currently taking fluphenazine decanoate or haloperidol decanoate, "may benefit from changing medication" and "willing to change", able to afford own medication, at least one 3‐monthly clinic visit in past 6 months. Included: eligible patients were those who might benefit from switching to risperidone microspheres (with sub‐optimal response to treatment because of persistent psychopathology or significant side effects); people where change in medical opinion was a reasonable clinical opinion, but not required; willingness to change antipsychotic medication; access to medication without financial burden; at least 1 clinic visit every 3 months for past 6 months. Excluded: symptom severity indicating immediate change; exacerbation in previous 3/12; pregnancy; pending criminal charges; non‐independent living; antipsychotic polypharmacy. Consent and ethics: written informed consent after thorough description of the study to participants and assessment of understanding consent materials. |
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Interventions | 1. Risperidone depot: 25, 37.5 or 50 mg/ 2 weeks, n = 32. 2. Haloperidol decanoate OR fluphenazine*, n = 30. *No data on dosages actually prescribed in this arm ‐ "clinician's judgement". |
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Outcomes | Primary ‐ time to all‐cause treatment discontinuation. Mental state: PANSS (completer‐only). Hospitalisation by 6 months. Adverse events: Arizona Sexual Experiences Scale; weight; prolactin (completer‐only, skew data). Unable to use ‐ AIMS (adapted scale used). Subjective Side‐effect Rating Scale (no data reported). EPS (SAS); tardive dyskinesia (incomplete data for all participants ‐ only 44% accounted for). Tardive dyskinesia (more than 50% participants did not complete assessment). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised, quote, "stratified by gender and baseline decanoate. No exceptions were made to the predetermined randomisation streams" (p670). |
Allocation concealment (selection bias) | Unclear risk | No details given of how this was achieved. Quote, "eligible patients were those who might benefit from a switch to risperidone microspheres" (p670). |
Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label study with assessment by blinded clinical raters. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Data relating to loss to follow‐up are given and overall attrition is < 50%. Lost to follow‐up n = 8: reasons for discontinuation included increase in psychiatric symptoms (n = 4), EPS concerns (n = 1), participant preference (n = 2), hypertension and weight gain (n = 1). However, not all participants completed continuous outcome measures; LOCF carried forward used in primary study citation, completer‐only data provided with means and SD for additional requested information (unpublished). |
Selective reporting (reporting bias) | High risk | Not all data reported, including means and SDs for most continuous outcomes. |
Other bias | Unclear risk | Funding: quote, "research presented in this article was funded by the National Institute of Mental Health grant number MH71663 and MH59312." One author (Schooler) "has previously received grant/research support from... Janssen‐Cilag, and Johnson & Johnson." |