Clinical Trials

Haloperidol has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, alongside non-phase-specific studies, for psychiatric and acute medical conditions including schizophrenia relapse, delirium, agitation, and cannabinoid hyperemesis syndrome. Sponsored by academic medical centers and universities, these trials reflect diverse recruitment statuses ranging from active and recruiting to completed or terminated. Collectively, this research assesses haloperidol's effectiveness in managing acute confusion, psychiatric emergencies, and critical care conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03743649 ACTIVE_NOT_RECRUITING
Delirium; Locally Advanced Malignant Neoplasm; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm
M.D. Anderson Cancer Center
 2019-07-17 PHASE2; PHASE3
NCT07109245 RECRUITING
Brain Insulin Sensitivity; Healthy Controls; Cognition
Centre for Addiction and Mental Health
 2025-12-11 PHASE4
NCT07726069 NOT_YET_RECRUITING
Cannabinoid Hyperemesis Syndrome
University of Illinois at Chicago
 2026-11 EARLY_PHASE1
NCT06218524 NOT_YET_RECRUITING
Glioblastoma Multiforme
Southern Medical University, China
 2024-12-01 PHASE2
NCT05431595 RECRUITING
Delirium; Epileptics; Neuroleptics
M.D. Anderson Cancer Center
 2022-07-19 PHASE2; PHASE3
NCT07246187 RECRUITING
Cannabinoid Hyperemesis Syndrome
Mercy Bon Secours Saint Vincent Medical Center
 2025-11-06 PHASE3
NCT06993194 NOT_YET_RECRUITING
Traumatic Brain Injury; Delirium; Agitation
Benha University
 2025-06-15
NCT06370442 UNKNOWN
Altered Mental Status
State University of New York - Upstate Medical University
 2024-06-01 PHASE3
NCT07087925 COMPLETED
Postoperative Nausea and Vomiting (PONV); Subarachnoid Block; Spinal Anesthesia
Rully Riyandika
 2025-01-15
NCT06395428 RECRUITING
Back Pain; Chronic Pain
Western Michigan University School of Medicine
 2024-07-09 PHASE4
NCT04529226 UNKNOWN
Psychosis; Intellectual Disability
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2020-11-26 PHASE2
NCT04071639 UNKNOWN
Huntington Disease
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2020-03-12 PHASE1
NCT04833023 UNKNOWN
Haloperidol; Advanced Cancer; Hyperactive Delirium; Olanzapine; End-stage Organ Disease
Tan Tock Seng Hospital
 2022-05-18 PHASE3
NCT05995457 UNKNOWN
Schizophrenia; Psychosis
Centre Hospitalier St Anne
 2023-09-01
NCT05803642 UNKNOWN
Acute Agitation
Qilu Pharmaceutical Co., Ltd.
 2023-03-28 PHASE3
NCT04750395 UNKNOWN
Delirium; Terminal Illness
HCA Hospice Care
 2021-09-01 PHASE2
NCT06428084 COMPLETED
Laparoscopic Cholecystectomy
Universitas Padjadjaran
 2023-11-01 PHASE2
NCT05065567 TERMINATED
Cyclic Vomiting Syndrome
Corewell Health South
 2021-08-30 PHASE3
NCT06168773 COMPLETED
Delirium in Old Age
Ain Shams University
 2022-11-01 PHASE2; PHASE3
NCT06076668 Recruiting
Dexmedetomidine|Melatonin|Delirium
Tanta University
 2023-10-16 Not Applicable
NCT06088069 Recruiting
Virtual Reality|Total Hip Arthroplasty|Anxiety|Stress|Pain
Tanta University
 2023-10-19 Not Applicable
NCT05690698 COMPLETED
Hyperactive Delirium
Alexandria University
 2023-04-09 PHASE3
NCT04764344 COMPLETED
Vomiting; Nausea; Abdominal Pain; Cannabis Use
Western Michigan University School of Medicine
 2021-04-01 PHASE4
NCT06014606 COMPLETED
Motivation
Maastricht University
 2021-03-01
NCT04715230 TERMINATED
Methamphetamine Intoxication (Disorder)
InterveXion Therapeutics, LLC
 2021-06-30 PHASE2
NCT03392376 UNKNOWN
Delirium
Zealand University Hospital
 2018-06-13 PHASE4
NCT05374356 Unknown status
Post-Operative Confusion
University of Manitoba
 2022-05 Not Applicable
NCT03021486 ACTIVE_NOT_RECRUITING
Advanced Malignant Neoplasm; Delirium; Locally Advanced Malignant Neoplasm; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm
M.D. Anderson Cancer Center
 2017-06-05 PHASE2; PHASE3
NCT04176055 COMPLETED
Cannabis Hyperemesis Syndrome
University of Calgary
 2020-10-13 PHASE4
NCT04327843 COMPLETED
Schizophrenia; Medication Nonadherence; Schizo Affective Disorder
Case Western Reserve University
 2019-11-05 PHASE3
NCT05246631 COMPLETED
Laparoscopy; Postoperative Nausea and Vomiting
Indonesia University
 2020-01-01 PHASE4
NCT03375671 COMPLETED
Violent Aggressive Behavior; Ketamine
David Barbic
 2018-05-29 PHASE2
NCT03628391 TERMINATED
Delirium; Critical Illness; Intensive Care Psychosis; Cognitive Impairment; Cognitive Decline
Erasmus Medical Center
 2018-02-22 PHASE3
NCT04411953 COMPLETED
Bioequivalence
Cycle Pharmaceuticals Ltd.
 2019-11-15 PHASE1
NCT04411940 COMPLETED
Bioequivalence
Cycle Pharmaceuticals Ltd.
 2019-11-15 PHASE1
NCT02431702 COMPLETED
Schizophrenia; Psychotic Disorders
Janssen Scientific Affairs, LLC
 2015-07-08 PHASE3
NCT03754062 COMPLETED
Haloperidol; Placebo; L-DOPA
King's College London
 2017-06-01 PHASE1
NCT02380118 TERMINATED
Acute Agitation, Behavioural Emergency
The University of Hong Kong
 2014-12 PHASE4
NCT03639558 COMPLETED
Psychiatric Emergency; Aggression; Agitation
Joseph Dib
 2018-08-28 PHASE4
NCT03056482 COMPLETED
Cannabis Use Disorder
Dr. Marco L.A. Sivilotti
 2017-05-21 PHASE4
NCT02433041 COMPLETED
Postoperative Delirium
University Hospital, Basel, Switzerland
 2013-07 PHASE4
NCT03199950 UNKNOWN
Delirium
Zuyderland Medisch Centrum
 2017-06-23 PHASE4
NCT01924468 COMPLETED
Nicotine Dependence
National Institute on Drug Abuse (NIDA)
 2013-08-14 PHASE1
NCT03075657 COMPLETED
Schizophrenia
All India Institute of Medical Sciences, Bhubaneswar
 2017-05-01 PHASE4
NCT03246620 TERMINATED
Acute Agitation; Behavioural Emergency
The University of Hong Kong
 2017-09-01 PHASE4
NCT03110900 TERMINATED
Agitation,Psychomotor; Haloperidol Causing Adverse Effects in Therapeutic Use; Lorazepam Causing Adverse Effects in Therapeutic Use; Loxapine Causing Adverse Effects in Therapeutic Use
University of Arkansas
 2017-09-30 PHASE4
NCT02345902 UNKNOWN
Hypoactive Delirium
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2016-01 PHASE3
NCT02343575 TERMINATED
Hyperactive Delirium; Mixed Delirium
Stanford University
 2015-01 PHASE4
NCT02240173 UNKNOWN
Schizophrenia and Disorders With Psychotic Features
Federal Neuro-Psychiatric Hospital, Yaba
 2017-06 PHASE1; PHASE2
NCT02625181 COMPLETED
Postoperative Nausea and Vomiting
Vanderbilt University
 2016-07
NCT02747511 COMPLETED
Headache; Migraine Disorders
Western Michigan University School of Medicine
 2015-10 PHASE4
NCT01211522 COMPLETED
Delirium; Impaired Cognition; Long Term Psychologic Disorders
Vanderbilt University Medical Center
 2011-12-14 PHASE3
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02972502 TERMINATED
Headache, Migraine
OhioHealth
 2014-02 PHASE4
NCT02909465 COMPLETED
Ketamine Induced Agitation
Tehran University of Medical Sciences
 2016-07 PHASE4
NCT01539733 COMPLETED
Delirium; Advanced Cancer
Amsterdam UMC, location VUmc
 2010-03
NCT03019887 COMPLETED
Schizophrenia Relapse
Juntendo University
 2011-04
NCT01785290 COMPLETED
Delirium
Radboud University Medical Center
 2013-06 PHASE4
NCT02057549 TERMINATED
Gastroparesis
The University of Texas Health Science Center, Houston
 2012-11 PHASE4
NCT01811459 COMPLETED
Delirium
Centre hospitalier de l'Université de Montréal (CHUM)
 2013-02 PHASE3
NCT01949662 ACTIVE_NOT_RECRUITING
Advanced Cancers
M.D. Anderson Cancer Center
 2014-01 PHASE2
NCT02307396 COMPLETED
Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders
Technical University of Munich
 2015-02-01 PHASE4
NCT02199743 COMPLETED
Schizophrenia; Schizoaffective Disorder
University of Texas Southwestern Medical Center
 2013-02 PHASE4
NCT02493192 UNKNOWN
Parturition; Humanizing Deliver; Labor Pain; Natural Childbirth; Labor Onset; First Labor Stage
Hospital General Universitario Gregorio Marañon
 2015-07 PHASE4
NCT02213900 COMPLETED
Delirium; Cognitive Impairment; Post-traumatic Stress Disorder; Depression; Anxiety
Indiana University
 2013-09 PHASE4
NCT01501123 COMPLETED
Agitation
Catholic Health East
 2011-11
NCT01862302 COMPLETED
Postoperative Confusion
McMaster University
 2013-08 PHASE3
NCT00842608 COMPLETED
Delirium; Cognitive Impairment
Indiana University
 2009-02
NCT02203786 COMPLETED
Pathological Gambling
Centre for Addiction and Mental Health
 2009-09 PHASE2
NCT01530308 COMPLETED
Delirium
Amsterdam UMC, location VUmc
 2012-11 PHASE4
NCT02098499 WITHDRAWN
Migraine Headaches; Nausea; Restlessness
United States Naval Medical Center, Portsmouth
 2013-06-12 PHASE4
NCT02103881 WITHDRAWN
Agitation
Hennepin Healthcare Research Institute
 2014-04 PHASE4
NCT01157351 COMPLETED
Schizophrenia
Janssen Scientific Affairs, LLC
 2010-05 PHASE4
NCT01174290 COMPLETED
Subsyndromal Delirium
Northeastern University
 2010-09 PHASE4
NCT01164059 COMPLETED
Schizophrenia
University of Bremen
 2010-02 PHASE4
NCT01136772 COMPLETED
Schizophrenia; Schizoaffective Disorder
New York State Psychiatric Institute
 2011-03 PHASE4
NCT01556932 COMPLETED
Nausea; Vomiting
Virginia Commonwealth University
 2012-03
NCT01684969 WITHDRAWN
Nausea; Vomiting
Eric E. Prommer
 2012-03 EARLY_PHASE1
NCT01750541 COMPLETED
Psychomotor Agitation
Shahid Beheshti University of Medical Sciences
 2012-12 PHASE3
NCT01639599 COMPLETED
Gynecological Disease
The Catholic University of Korea
 2012-03
NCT01193166 WITHDRAWN
Schizophrenia
Ortho-McNeil Janssen Scientific Affairs, LLC
 2010-08 PHASE4
NCT01152697 COMPLETED
Patient Noncompliance
University Hospitals Cleveland Medical Center
 2010-06
NCT02143531 COMPLETED
Postoperative Nausea and Vomiting
American University of Beirut Medical Center
 2008-09 PHASE4
NCT01052389 COMPLETED
Schizophrenia
Mario Negri Institute for Pharmacological Research
 2007-07 PHASE4
NCT01140529 TERMINATED
Postoperative; Delirium; Psychomotor; Confusion
Thorax-Kärlkliniken
 2010-05 PHASE3
NCT00753051 COMPLETED
Schizophrenia
Khon Kaen University
 2008-06
NCT00833300 TERMINATED
Delirium; Agitation
Richard Hall
 2008-06
NCT01259973 UNKNOWN
Pharmacogenetics; Healthy
Hospital Clinic of Barcelona
 2011-02 PHASE1
NCT00300391 TERMINATED
Delirium
University of Pittsburgh
 2006-03 PHASE3
NCT01939093 COMPLETED
Methamphetamine-induced Psychosis
Chulalongkorn University
 2010-03 PHASE4
NCT01161277 COMPLETED
Psychosis; Schizophrenia
Oslo University Hospital
 2010-08 PHASE4
NCT01204255 COMPLETED
Healthy
Virginia Commonwealth University
 2010-11-15
NCT00954603 TERMINATED
Delirium
Chiang Mai University
 2009-06 PHASE3
NCT01485692 COMPLETED
Psychomotor Agitation
University of Sao Paulo
 2009-02
NCT01193621 COMPLETED
Healthy
Asan Medical Center
 2008-01 PHASE1
NCT00866645 COMPLETED
Agitation
Shanghai Mental Health Center
 2009-02 PHASE2; PHASE3
NCT00838032 UNKNOWN
Acute Schizophrenia
Sichuan University
 2008-08 PHASE4
NCT00615797 COMPLETED
Sydenham Chorea; Post Streptococcal Movement Disorder
University of Cape Town
 2002-05
NCT00642369 COMPLETED
Schizophrenia
Guang Dong Provincial Mental Health Institute
 2008-03
NCT00998608 TERMINATED
Schizophrenia
Kaohsiung Kai-Suan Psychiatric Hospital
 2007-08 PHASE4
NCT00723606 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2008-09 PHASE3
NCT00797277 COMPLETED
Schizophrenia; Schizoaffective Disorder; Agitation
National Taiwan University Hospital
 2006-07 PHASE3
NCT00395915 UNKNOWN
Schizophrenia
Universita di Verona
 2006-09 PHASE4
NCT00859872 COMPLETED
Schizophrenia
Central South University
 2008-08 PHASE4
NCT00129220 COMPLETED
Bipolar Disorder
Eli Lilly and Company
 2005-07 PHASE3
NCT00693472 TERMINATED
Akathisia, Drug-Induced; Antipsychotic Agents; Movement Disorders
Merck Sharp & Dohme LLC
 2007-08-15 PHASE2
NCT00250237 COMPLETED
Post-Operative Delirium; Hip Fracture
Bronovo Hospital
 2005-11 PHASE3
NCT00505804 COMPLETED
Delirium; Agitation; Ventilator Weaning; Respiration, Artificial; Intensive Care
Austin Health
 2005-01 PHASE2
NCT00457366 COMPLETED
Agitation
University of Southern California
 2006-05 PHASE4
NCT00124930 TERMINATED
Nausea; Neoplasms
Alberta Health services
 2005-05 PHASE3
NCT00599287 TERMINATED
Delirium
UMC Utrecht
 2008-02 PHASE3
NCT00631722 COMPLETED
Schizophrenia
Peking University
 2007-05
NCT00419653 TERMINATED
Schizophrenia
University of Jena
 2003-01 PHASE4
NCT00429676 COMPLETED
Delirium; Critical Illness
University of Colorado, Denver
 2005-12 PHASE2
NCT00156065 COMPLETED
Schizophrenia
Organon and Co
 2005-09 PHASE3
NCT00096863 COMPLETED
Delirium; Cognition Disorders
Vanderbilt University
 2004-12 PHASE2
NCT00740259 COMPLETED
Schizophrenia
Ambulatório de Bipolaridade
 2004-09 PHASE4
NCT00097266 COMPLETED
Bipolar Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2004-12 PHASE3
NCT00156104 COMPLETED
Schizophrenia
Organon and Co
 2005-07-01 PHASE3
NCT00947375 TERMINATED
Schizophrenia
Central Mental Clinic for Outpatients of Baku City
 2005-01 PHASE4
NCT00340379 COMPLETED
Affective Disorders
Duke University
 2003-04 PHASE2; PHASE3
NCT00625014 COMPLETED
Insulin Resistance; Dyslipidemia
Leiden University Medical Center
 2005-03
NCT00159081 COMPLETED
Schizophrenia
Heinrich-Heine University, Duesseldorf
 2000-11 PHASE4
NCT00767715 TERMINATED
Bipolar Disorder
Eli Lilly and Company
 2004-10 PHASE4
NCT00009217 COMPLETED
Alzheimer's Disease; Psychosis; Agitation
New York State Psychiatric Institute
 1999-01 PHASE4
NCT00625170 COMPLETED
Insulin Resistance; Dyslipidemia
Leiden University Medical Center
 2004-05
NCT01123408 COMPLETED
Schizophrenia
Nathan Kline Institute for Psychiatric Research
 1999-06
NCT00169091 TERMINATED
Schizophrenia
Harvard Medical School (HMS and HSDM)
 1996-03 PHASE4
NCT00044044 COMPLETED
Schizophrenia
Sumitomo Pharma America, Inc.
 2002-07 PHASE2
NCT00007774 COMPLETED
Schizoaffective Disorder; Schizophrenia
US Department of Veterans Affairs
 1998-03 PHASE4
NCT00946491 COMPLETED
Psychosis
Sandoz
 1987-04 PHASE1
NCT00249145 COMPLETED
Dementia; Alzheimer Disease; Dementia, Vascular
Janssen Pharmaceutica N.V., Belgium
 1995-04 PHASE3
NCT00361166 COMPLETED
Schizophrenia
ACADIA Pharmaceuticals Inc.
 2005-08 PHASE2
NCT00000179 COMPLETED
Alzheimer Disease
National Institute on Aging (NIA)
 PHASE3
NCT00000274 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
 1997-03 PHASE2
NCT00203775 TERMINATED
Psychosis; Aggression
University of Connecticut
 2002-07
NCT00455234 COMPLETED
Psychotic Disorders; Aggression
Christian Medical College, Vellore, India
 2005-09 PHASE3
NCT00191555 COMPLETED
Schizophrenia
Eli Lilly and Company
 2003-08 PHASE4
NCT00018850 COMPLETED
Schizophrenia
US Department of Veterans Affairs
 1998-06
NCT00174590 TERMINATED
Major Depression With Psychotic Features
Rush University Medical Center
 2001-09 PHASE3
NCT00249132 COMPLETED
Schizophrenia; Psychotic Disorders
Janssen, LP
 PHASE3
NCT00018642 COMPLETED
Schizophrenia; Schizoaffective Disorder
US Department of Veterans Affairs
 1997-04
NCT00189995 WITHDRAWN
Schizophrenia
Beersheva Mental Health Center
 PHASE3
NCT00174603 TERMINATED
Major Depression With Psychotic Features
Rush University Medical Center
 2005-08 PHASE3
NCT00485901 COMPLETED
Schizophrenia
Eli Lilly and Company
 2004-07 PHASE3
NCT00157378 UNKNOWN
Schizophrenia, First-Episode
Ludwig-Maximilians - University of Munich
 2000-11 PHASE4
NCT00534183 COMPLETED
Metabolic Syndrome; Diabetes; Obesity
Central Institute of Psychiatry, Ranchi, India
 2006-06
NCT00126009 COMPLETED
Bipolar Disorder
Sanofi
 2004-05 PHASE2
NCT00253162 COMPLETED
Bipolar Disorders; Manic Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2001-03 PHASE3
NCT00249119 COMPLETED
Schizophrenia; Psychotic Disorder
Janssen, LP
 PHASE3
NCT00253110 COMPLETED
Schizophrenia; Schizoaffective Disorder
Janssen, LP
 1996-05 PHASE4
NCT00253149 COMPLETED
Bipolar Disorders; Manic Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-15)

Check the Haloperidol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Haloperidol acts as a high-affinity antagonist primarily targeting central dopamine D2 receptors, which blocks downstream G-protein-coupled dopaminergic neurotransmission and attenuates hyperactive mesolimbic signal transduction. This targeted reduction in central dopaminergic activity suppresses excessive cellular signaling, providing therapeutic modulation of psychotic symptoms and acute behavioral disturbances evaluated in clinical trials for schizophrenia, agitation, and delirium.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.