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. 2007 Oct 17;2007(4):CD001943. doi: 10.1002/14651858.CD001943.pub2

Dubin 1996.

Methods Allocation: randomised ‐ randomisation table.
 Blinding: double ‐ identical ampules, staff administering medication not blinded, assessors blind.
 Duration: 6 days ‐ preceded by 24h washout (only data from first 72 hours used).
 Setting: single centre.
Participants Diagnosis: schizophrenia (52), bipolar manic (9) (DSM‐III).
 N=61.
 Age: mean ˜ 35 years, range 18‐65.
 Sex: ˜27 M, ˜31 F.
 Inclusion : BPRS score of 6/7 in >2 prespecified symptom categories.
 History: admitted as psychiatric emergency, healthy, drug sensitivity, not pregnant or lactating, no co‐existing mental illness.
Interventions 1. Loxapine: dose mean 75.5 mg/day IM, range 25‐175 mg/day IM. N=30.
 2. Thiothixene: dose mean 31 mg/day IM, range 20‐60 mg/day IM, N=31.
IM for first 24 hours, then oral. IM injections every 30 minutes as needed, until BPRS reduced or sedation occurred. Chloral hydrate, trihexyphenidyl/benztropine as required.
Outcomes Global effect (sedation, requiring further injections).
 Dropped from study.
Unable to use ‐ 
 Global effect: CGI (no data).
 Mental state: BPRS (no SD).
 Side effects: (only data for 5 day oral phase available).
 Physiological measures: BP, pulse (no data).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate