drugset / Trial / NCT00954603

A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium

NCT00954603 ↗

Phase 3 Terminated 52 enrolled Chiang Mai University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.

Timeline

Start
2009-06
Primary completion
2011-04
Completion
2012-07

Outcome

Missed primary endpoint

Stopped (Enrollment): “few delirious patients were enrolled.”

paper DRS-R-98 severity scores were not significantly different between the quetiapine and haloperidol groups (-22.9 [6.9] versus -21.7 [6.7]; P = 0.59). PMID 23926422 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Haloperidol Other / unclassified 0.5 mg —
Comparator Haloperidol Other / unclassified 2 mg —
Subject Quetiapine Small molecule 25 mg —
Subject Quetiapine Small molecule 100 mg —

Indications