Fruensgaard 1977.
Methods | Allocation: randomised ‐ no further details. Blinding: double ‐ identical ampules. Duration: 72 hours ‐ preceded by 12 h washout (study continued for 4 weeks but not reported). Setting: single centre. | |
Participants | Diagnosis: acute schizophrenia (12), psychogenic psychosis (18). N=30. Age: mean ˜ 40 years, range 19‐65. Sex: 7 M, 23 F. Inclusion: healthy, not pregnant, no coexisting mental illness, mania or treatment with ECT in last 8 weeks. History: duration of present episode: <1week (14), 1 week‐1 month (13), >1month (3). | |
Interventions | 1. Loxapine: dose 25‐50 mg/6‐12 hours IM, mean 130 mg/day IM. N=15.
2. Thiothixene: dose 2.5‐5 mg/6‐12 hours IM, mean 12 mg/day IM. N=15. Both given with biperiden. IM for first 24 hours, then oral. IM injections every 30 minutes as needed, until BPRS reduced or sedation occurred. |
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Outcomes | Global effect: CGI, sedation.
Adverse effects: pain at injection site. Unable to use ‐ Mental state: BPRS (no SD), continued aggression (no usable data). Physiological measures: BP, pulse (no data). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |