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ClinicalTrials.gov public records Last synced Jul 22, 2026, 11:54 AM EDT

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Showing 1–24 of 31 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Agitation Associated With Clear all
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

NCT04268303
View directory record Official record
Conditions
Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder, Schizophreniform Disorders
Interventions
Sublingual film containing dexmedetomidine (BXCL501), Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
15
States / cities
Little Rock, Arkansas • Cerritos, California • Culver City, California + 12 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Completed No phase listed Observational

Neuronal Ceroid Lipofuscinosis and Associated Sleep Abnormalities

NCT01966757
View directory record Official record
Conditions
Neuronal Ceroid Lipofuscinosis, Batten's Disease
Interventions
Not listed
Lead sponsor
Nationwide Children's Hospital
Other
Eligibility
Not listed
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 25, 2016 · Synced Jul 22, 2026, 11:54 AM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

NCT06947941
View directory record Official record
Conditions
Alzheimer Disease, Psychosis
Interventions
KarXT, KarX-EC, KarXT + KarX-EC Arm Matching Placebo
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
55 Years to 90 Years
Enrollment
325 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
6
States / cities
Gilbert, Arizona • Chino, California • Naples, Florida + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

NCT06937229
View directory record Official record
Conditions
Alzheimer Disease, Agitation
Interventions
KarXT, KarX-EC
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
55 Years to 90 Years
Enrollment
650 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
48
States / cities
Chandler, Arizona • Scottsdale, Arizona • Anaheim, California + 41 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 3 Interventional Results available

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

NCT01862640
View directory record Official record
Conditions
Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
Interventions
Brexpiprazole, OPC-34712, Placebo Oral Tablet
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
433 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
37
States / cities
Tuscaloosa, Alabama • Phoenix, Arizona • Bellflower, California + 25 more
Source: ClinicalTrials.gov public record
Updated Dec 30, 2020 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)

NCT05271552
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
151 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
11
States / cities
Phoenix, Arizona • Long Beach, California • Daytona Beach, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Dec 30, 2025 · Synced Jul 22, 2026, 11:54 AM EDT
Recruiting Not applicable Interventional Accepts healthy volunteers

Virtual Reality to Reduce Anxiety, Agitation and Delirium in Critically Ill Patients

NCT07649876
View directory record Official record
Conditions
Delirium in the Intensive Care Unit, Sleep Quality in Adult ICU Patients, Agitation Associated With Critical Illness, Anxiety Acute
Interventions
Virtual reality (VR) therapy
Behavioral
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
Not listed
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026
U.S. locations
1
States / cities
Hershey, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Recruiting Phase 1 Interventional

Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

NCT05025605
View directory record Official record
Conditions
Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II
Interventions
BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
10 Years to 17 Years
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
5
States / cities
Anaheim, California • Hialeah, Florida • Atlanta, Georgia + 2 more
Source: ClinicalTrials.gov public record
Updated Apr 12, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

NCT04251910
View directory record Official record
Conditions
Agitation,Psychomotor, Dementia
Interventions
Sublingual film containing Dexmedetomidine, Sublingual Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
5
States / cities
Homestead, Florida • Miami Lakes, Florida • Springfield, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 2, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Completed No phase listed Observational

Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo

NCT02192554
View directory record Official record
Conditions
Agitation Associated With Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
Interventions
Not listed
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
Not listed
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
28
States / cities
Tuscaloosa, Alabama • Costa Mesa, California • Lakewood, California + 21 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2018 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 1 Interventional

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

NCT04010305
View directory record Official record
Conditions
Agitation, Schizophrenia
Interventions
Sublingual film containing BXCL501 (Dexmedetomidine), Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
135 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
12
States / cities
Little Rock, Arkansas • Cerritos, California • Lemon Grove, California + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 7, 2023 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 3 Interventional Results available

A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

NCT03594123
View directory record Official record
Conditions
Alzheimer's Disease
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 91 Years
Enrollment
259 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 13, 2023 · Synced Jul 22, 2026, 11:54 AM EDT
Terminated Phase 2 Interventional Results available

An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

NCT05276830
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
3
States / cities
North Miami, Florida • Springfield, Massachusetts • Toms River, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 2, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 3 Interventional Results available

Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

NCT01922258
View directory record Official record
Conditions
Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
Interventions
Brexpiprazole, OPC-34712
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
270 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
28
States / cities
Imperial, California • Lakewood, California • Long Beach, California + 21 more
Source: ClinicalTrials.gov public record
Updated Nov 19, 2020 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

NCT04276883
View directory record Official record
Conditions
Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
Interventions
Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
15
States / cities
Little Rock, Arkansas • Cerritos, California • Culver City, California + 12 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 3 Interventional Results available

Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

NCT00748098
View directory record Official record
Conditions
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Interventions
GSK1838262 Extended Release Tablets, Placebo
Drug
Lead sponsor
XenoPort, Inc.
Industry
Eligibility
18 Years and older
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
24
States / cities
Jasper, Alabama • San Diego, California • Hallandale, Florida + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2013 · Synced Jul 22, 2026, 11:54 AM EDT
Suspended No phase listed Observational

Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

NCT03513549
View directory record Official record
Conditions
Agitation,Psychomotor
Interventions
Loxapine 10 MG
Drug
Lead sponsor
Alexza Pharmaceuticals, Inc.
Other
Eligibility
18 Years and older
Enrollment
10,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2027
U.S. locations
1
States / cities
Raleigh, North Carolina
Source: ClinicalTrials.gov public record
Updated Oct 20, 2025 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 2 Interventional

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder

NCT07116694
View directory record Official record
Conditions
Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychomotor Agitation
Interventions
BXCL501 Sublingual Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
5
States / cities
Chino, California • Oceanside, California • Orange, California + 2 more
Source: ClinicalTrials.gov public record
Updated Apr 5, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Terminated Not applicable Interventional

Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients

NCT01316536
View directory record Official record
Conditions
Music Therapy for Pain and Sedation
Interventions
provide headphones with music playing, Sounds
Other
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years to 70 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Apr 16, 2015 · Synced Jul 22, 2026, 11:54 AM EDT
Not listed Phase 4 Interventional

Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome

NCT02424695
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
Gabapentin Enacarbil (GEn), Placebo
Drug
Lead sponsor
Cleveland Sleep Research Center
Other
Eligibility
18 Years to 65 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Middleburg Heights, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 22, 2015 · Synced Jul 22, 2026, 11:54 AM EDT
Withdrawn Phase 2 Interventional

Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

NCT05313386
View directory record Official record
Conditions
Agitation, Delirium
Interventions
BXCL501, Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Apr 5, 2022 · Synced Jul 22, 2026, 11:54 AM EDT
Recruiting Phase 2 Interventional

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

NCT06651567
View directory record Official record
Conditions
Agitation Associated With Alzheimer's Dementia
Interventions
ITI-1284, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
55 Years and older
Enrollment
320 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
31
States / cities
Anaheim, California • Costa Mesa, California • Garden Grove, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jul 5, 2026 · Synced Jul 22, 2026, 11:54 AM EDT
Terminated Phase 3 Interventional

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

NCT05665088
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
7
States / cities
Los Alamitos, California • Daytona Beach, Florida • Maitland, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Dec 10, 2023 · Synced Jul 22, 2026, 11:54 AM EDT
Completed Phase 3 Interventional Results available

Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

NCT00991276
View directory record Official record
Conditions
Restless Legs Syndrome
Interventions
pregabalin, placebo, pramipexole
Drug
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Eligibility
18 Years and older
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
41
States / cities
Jasper, Alabama • Phoenix, Arizona • Tucson, Arizona + 35 more
Source: ClinicalTrials.gov public record
Updated Feb 14, 2021 · Synced Jul 22, 2026, 11:54 AM EDT