Haloperidol for Delirium

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Delirium+3 More
Haloperidol - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is examining the effects of different drugs in conjunction with standardized non-pharmacologic interventions to treat agitated delirium in cancer patients.

Eligible Conditions
  • Delirium
  • Epileptics
  • Neuroleptics

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: through study completion, an average of 1 year

Year 1
Edmonton Symptom Assessment Scale Questionnaire

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Lurasidone (LUR)
21%Sedation
21%Insomnia
14%Stiffness in jaw
7%diabetes mellitus
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT02199743) in the Lurasidone (LUR) ARM group. Side effects include: Sedation with 21%, Insomnia with 21%, Stiffness in jaw with 14%, diabetes mellitus with 7%.

Trial Design

4 Treatment Groups

Group 1
1 of 4
Group 3
1 of 4
Group 2
1 of 4
Group 4
1 of 4

Experimental Treatment

150 Total Participants · 4 Treatment Groups

Primary Treatment: Haloperidol · Has Placebo Group · Phase 2 & 3

Group 1
Drug
Experimental Group · 1 Intervention: Haloperidol · Intervention Types: Drug
Group 3
Drug
Experimental Group · 1 Intervention: Valproate · Intervention Types: Drug
Group 2
Drug
Experimental Group · 1 Intervention: Chlorpromazine · Intervention Types: Drug
Group 4
Drug
Experimental Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Haloperidol
2013
Completed Phase 4
~1238310
Placebo
1995
Completed Phase 3
~2670
Chlorpromazine
2010
Completed Phase 4
~930
Valproate
2021
Completed Phase 4
~2940

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,780 Previous Clinical Trials
1,784,660 Total Patients Enrolled
5 Trials studying Delirium
594 Patients Enrolled for Delirium
Cancer Prevention Research Institute of TexasOTHER
41 Previous Clinical Trials
78,761 Total Patients Enrolled
David Hui, MDPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
1,240 Total Patients Enrolled
1 Trials studying Delirium
93 Patients Enrolled for Delirium

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of advanced cancer.
Hyperactive or mixed delirium in the past 24 h requiring at least 1 dose of rescue medication.
You have received a referral from a primary care clinician.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.