Objective To compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness. Design Pragmatic, allocation concealed, randomised controlled trial. Setting Emergency services of a general hospital psychiatry department in Vellore, south India. Participants 300 adults with agitated or violent behaviour as a result of mental illness; 150 randomised to intramuscular olanzapine and 150 randomised to intramuscular haloperidol plus promethazine. Interventions Open treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine. Main outcome measures Primary outcome was proportion of patients who were tranquil or asleep at 15 minutes and 240 minutes. Secondary outcomes were proportion of patients who were tranquil, asleep, restrained, absconding, or clinically improved at 15, 30, 60, 120, and 240 minutes; additional medical interventions and adverse effects over four hours; and compliance with oral drugs and adverse effects over two weeks. Results Of 300 people randomised to receive either intramuscular olanzapine or intramuscular haloperidol plus promethazine, follow-up data were available for primary outcomes for 298 (99%). Both treatments resulted in similar proportions of people being tranquil or asleep at 15 minutes (olanzapine 131/150 (87%), haloperidol plus promethazine 136/150 (91%); relative risk 0.96, 95% confidence interval 0.34 to 1.47) and 240 minutes (olanzapine 144/150 (96%), haloperidol plus promethazine 145/150 (97%); relative risk 0.99, 0.95 to 1.03). However, more people given olanzapine than those given haloperidol plus promethazine required additional drugs over four hours (65/150 (43%) v 31/150 (21%); relative risk 2.07, 1.43 to 2.97). Adverse effects were uncommon with both treatments.

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Both interventions are effective for controlling violent/agitated behaviour. If speed of sedation is required, the haloperidol-promethazine combination has advantages over lorazepam.

In a double-blind comparative trial of sulpiride (600-1,800 mg/day) and trifluoperazine (15-45 mg/day) in 38 chronic schizophrenic patients, ratings of therapeutic results and unwanted effects were made at two-weekly interviews during the six weeks treatment period. The results show that sulpiride has neuroleptic properties and a spectrum of therapeutic activity similar to that of trifluoperazine. There was an association between plasma sulpiride levels and therapeutic response after four weeks' treatment.