Hoyberg 1993.
Methods | Allocation: randomised (no further description). Blindness: double (identicle appearance of medication). Duration: 8 weeks. Consent: given. Setting: multicentre, multinational. | |
Participants | Diagnosis: schizophrenia (DSM‐III‐R). N=107. Sex: 77M, 30F. Age: 20‐67 years, mean ˜ 36 years. History: chronic. Exclusions: other significant physical or psychological illness, abnormal lab results, substance abuse, oral neuroleptics within 3 days of trial, depot neuroleptics within 3 weeks of trial, pregnant or nursing females, females of child bearing potential without adequate contraception. | |
Interventions | 1. Risperidone: initially 5mg/day adjusted according to clincial judgement, 5‐15mg/day 1‐28, FD (if possible) thereafter. N=55. 2. Perphenazine: 16‐48mg/day, an initial dose of 16mg/day was adjusted as required days 1‐28, FD (if possible) thereafter. N=52. | |
Outcomes | Clinical improvement: >20% reduction in total PANSS or BPRS score,
Global effect: CGI improved/not improved.
Adverse effects: use of antiparkinsonian medication.
Leaving the study early. Unable to use ‐ Severity of illness: CGI severity (no SD). Mental state: PANSS, BPRS‐PANSS derived (no SD). Physiological monitoring: ECG, lab tests (insufficient data). Adverse effects: ESRS, UKU (no SD). |
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Notes | Intention‐to‐treat analysis for adverse effects. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |