Glazer 1985.
Methods | Allocation: randomised. Blindness: double. Design: parallel. Duration: 6 weeks. Setting: TD Clinic at the Connecticut Mental Health Center, Yale University School of Medicine. |
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Participants | Diagnosis: schizophrenia (25), schizoaffective disorder (4), other; unspecified (2). antipsychotic medication for at least 6 months; TD (AIMS) for at least 6 months prior to the study. Duration of TD: around 2 years. N = 31. Sex: 16 male and 15 female. Age: baclofen, 46.5 (SD 12.2) years; range 27‐65 years. Placebo, 47.1 (SD14.1) years; range 26‐67 years. |
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Interventions | 1. Baclofen: maximum dose 90 mg/d for 6 weeks. N = 16 (completers).* 2. Placebo: 6 weeks. N = 15 (completers).* Doses of antipsychotic medications stable for at least 4 weeks prior to randomisation. During the study, patients were maintained on the dose of antipsychotic medication that they were on upon entry into the study. Concomitant medication: not reported. |
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Outcomes | TD symptoms: AIMS. Mental state. Adverse effects. |
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Notes | Sponsorship source: Supported in part by NIMH and CIBA‐GEIGY Corporation. "Patients were dropped from the study if poor compliance was suspected." *No information about numbers initially randomised (only those completing were analysed); authors contacted and confirmed that those who left early were not included in analyses. No additional data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized" Details not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "double‐blind" Details not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | TD symptoms and mental state: "double‐blind". Details not reported. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Number of participants enrolled and randomised to each group not reported. Only participants who completed were reported and analysed. |
Selective reporting (reporting bias) | High risk | TD symptoms (total AIMS scores) reported as means only. |
Other bias | Low risk | Mean duration of TD, antipsychotic use (dose), mean duration of psychiatric diagnoses, and psychiatric diagnoses reported for both groups are similar. The study seems to be free of other sources of bias. |