NCT01811459.

Trial name or title	Randomized trial comparing haloperidol, quetiapine, and placebo in the pharmacological treatment of delirium (Haloquet)
Methods	Single‐site, quadruple‐blind, randomized placebo‐controlled study taking place in Canada. Target enrolment: 107 participants
Participants	Adult (≥ 18 years) ICU patients diagnosed with delirium by a psychiatrist (DSM criteria)
Interventions	Participants randomized to 1 mg intravenous haloperidol and oral placebo, 50 mg oral quetiapine and intravenous placebo, or intravenous and oral placebo As needed 2 mg intravenous doses of haloperidol permitted every 30 minutes to all participants until delirium symptoms resolve. Incremental titration (1 mg haloperidol or 50 mg quetiapine) permitted twice daily if 2 doses of as needed haloperidol were given in the previous 24 hours. Additional rescue doses of 5 mg of intravenous haloperidol were permitted every 30 minutes to all participants if agreed by the treating physician Treatment continued until: delirium resolution 21 days of treatment ICU discharge; or life‐threatening adverse event potentially attributable to the study drug
Outcomes	Primary Time to first resolution of delirium Secondary Days of delirium, duration of delirium Severity of delirium ICU and hospital mortality ICU and hospital length of stay Duration of mechanical ventilation Time spent deeply sedated (i.e. RASS < 3) Episodes of subject‐initiated device removal Use of as needed and rescue haloperidol therapy Average daily and maximum total antipsychotic doses (haloperidol equivalents) Duration of study drug administration Use of benzodiazepines Use of opioids QTc prolongation Extrapyramidal symptoms Neuroleptic malignant syndrome
Starting date	February 2013
Contact information	Nicholas Bergeron (nbergeron@yahoo.com) Marie‐Pierre Leduc (marie‐pierre.leduc.chum@ssss.gouv.qc.ca)
Notes	Study recruitment complete and data analysis phase in progress as of December 2017 (communication with principal investigators) Sponsor: Centre Hopitalier de l'Université de Montréal Study registered: at clinicaltrials.gov under NCT01811459