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Objective:

To compare the efficacy and safety of scheduled quetiapine to placebo for the treatment of delirium in critically ill patients requiring as-needed haloperidol.

Design:

Prospective, randomized, double-blind, placebo-controlled study.

Setting:

Three academic medical centers.

Patients:

Thirty-six adult intensive care unit patients with delirium (Intensive Care Delirium Screening Checklist score≥ 4), tolerating enteral nutrition, and without a complicating neurologic condition.

Interventions:

Patients were randomized to receive quetiapine 50 mg every 12 hrs or placebo. Quetiapine was increased every 24 hrs (50 to 100 to 150 to 200 mg every 12 hrs) if more than one dose of haloperidol was given in the previous 24 hrs. Study drug was continued until the intensive care unit team discontinued it because of delirium resolution, therapy≥ 10 days, or intensive care unit discharge.

Measurements and Main Results:

Baseline …