Clinical trials: Agitation, Psychomotor
Aggressive Behavior in Fragile X Syndome
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
The goal of this clinical trial is to learn if drug SRX246 works to treat irritability, agitation, aggression and self-injury (IAAS) behaviors in adult males with Fragile X Syndrome (FXS).
- Trial name
- NCT07328529
- Testing
- SRX246
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Azevan Pharmaceuticals
Agitation
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.
- Trial name
- NCT06052254
- Testing
- 12 cm2 - 2 Active DMTS Patches
- Where
- 8 sites in United States
- Volunteers
- 150 people
- Sponsor
- Teikoku Pharma USA, Inc.
Dementia, Agitation
Virtual Reality to Advance Dementia Care and Quality of Life
The goal of this feasibility clinical trial is to learn whether supervised virtual reality (VR) sessions can be safely and practically provided to adults aged 55 years and older with moderate-to-severe dementia who experience…
- Conditions
- Dementia, Agitation, Behavioural and Psychological Symptoms of Dementia, Major Neurocognitive Disorder
- Trial name
- VR-Care (NCT07893678)
- Testing
- Supervised Virtual Reality Sessions
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Delirium in the Intensive Care Unit, Sleep Quality in Adult ICU Patients
Virtual Reality to Reduce Anxiety, Agitation and Delirium in Critically Ill Patients
This is a pilot feasibility study examining the use of immersive virtual reality (VR) in adult intensive care unit (ICU) patients.
- Conditions
- Delirium in the Intensive Care Unit, Sleep Quality in Adult ICU Patients, Agitation Associated With Critical Illness, Anxiety Acute
- Trial name
- NCT07649876
- Testing
- Virtual reality (VR) therapy
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
Delirium, Critical Illness
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Ventilated pediatric patients are frequently over-sedated and the majority suffer from delirium, a form of acute brain dysfunction that is an independent predictor of increased risk of dying, length of stay, and costs.
- Conditions
- Delirium, Critical Illness, Sedation Complication, Executive Dysfunction
- Trial name
- mini-MENDS (NCT04801589)
- Testing
- Dexmedetomidine, Midazolam
- Where
- United States
- Volunteers
- 372 people
- Sponsor
- Vanderbilt University Medical Center
Alzheimer Disease, Agitation
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in…
- Trial name
- NCT06937229
- Testing
- KarXT, KarX-EC
- Where
- 252 sites in United States, Argentina and 24 more
- Volunteers
- 650 people
- Sponsor
- Bristol-Myers Squibb
Alzheimer's Disease
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
- Trial name
- NCT07011745
- Testing
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule
- Where
- 143 sites in United States, Argentina and 12 more
- Volunteers
- 426 people
- Sponsor
- Bristol-Myers Squibb
Agitation, Alzheimer Disease
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
- Trial name
- NCT06808984
- Testing
- BMS-986368
- Where
- 77 sites in United States, Argentina and 2 more
- Volunteers
- 120 people
- Sponsor
- Celgene
Bipolar I Disorder, Bipolar II Disorder
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT07116694
- Testing
- BXCL501 Sublingual Film
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation, Dementia
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)
A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 168 doses within a 12-week treatment period.
- Trial name
- NCT05665088
- Testing
- BXCL501
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- BioXcel Therapeutics Inc
Dementia
Decoding Death and Dying in People With Dementia by Digital Thanotyping
How can healthcare professionals recognize that a person with dementia is at the end of life? When people are dying, their physical, mental, and social abilities are gradually declining.
- Trial name
- 5-D (NCT06437132)
- Testing
- No intervention
- Where
- Norway
- Volunteers
- 270 people
- Sponsor
- University of Bergen
Alzheimer Disease, Agitation,Psychomotor
Clinical Trial on Agitation in Alzheimer's Dementia
The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from…
- Conditions
- Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden, NPS
- Trial name
- CALMA (NCT05543681)
- Testing
- IGC-AD1-Active
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 164 people
- Sponsor
- IGC Pharma, LLC
Delirium, Sedation
Neurosteer Bedside Monitoring System
The purpose of this study is to evaluate the clinical utility of Neurosteer's brain monitoring platform for monitoring delirium, sedation, and agitation in intubated and sedated ICU patients.
- Conditions
- Delirium, Sedation, Agitation
- Trial name
- NCT06718764
- Testing
- Neurosteer's single-channel EEG monitoring device
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Agitation, Alzheimer's Type Dementia
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
- Trial name
- NCT05397639
- Testing
- Masupirdine 50 mg, Masupirdine 100 mg
- Where
- 44 sites in United States, Croatia and 2 more
- Volunteers
- 375 people
- Sponsor
- Suven Life Sciences Limited
Alcoholism
Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU
Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA) considers alcohol abuse to be more than 14…
- Trial name
- BACLOREA (NCT02723383)
- Testing
- BACLOFEN
- Where
- 18 sites in France
- Volunteers
- 314 people
- Sponsor
- Nantes University Hospital
Dementia
Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia
This randomized, controlled, longitudinal clinical trial investigates the effects of Snoezelen Multisensory Therapy (SMT) as an adjunct to standard therapy (ST) in older adults with dementia.
- Trial name
- SMT (NCT07657208)
- Testing
- Snoezelen Multisensory Therapy, Standard Therapy
- Where
- Slovenia
- Volunteers
- 63 people
- Sponsor
- University of Primorska
Dexmedetomidine, Ketamine
Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial
This investigator-initiated, randomized, controlled, single-blind, superiority trial aims to assess the efficacy and safety of esketamine combined with dexmedetomidine for the management of agitation or delirium in intensive care…
- Conditions
- Dexmedetomidine, Ketamine, Analgesia, Respiratory Therapy
- Trial name
- SEED-NIRS (NCT07377981)
- Testing
- Esketamine combined with dexmedetomidine, Dexmedetomidine
- Where
- China
- Volunteers
- 356 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Agitation, Dementia
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks.
- Trial name
- LiBBY (NCT05644262)
- Testing
- T2:C100
- Where
- 10 sites in United States
- Volunteers
- 120 people
- Sponsor
- University of Southern California
Anxiety, Agitation
Family Videos and Virtual Reality in Intensive Care Patients
This randomized controlled trial was conducted to evaluate the effects of family videos and virtual reality-based nature videos on anxiety, agitation, pain, and vital signs in adult intensive care unit patients.
- Conditions
- Anxiety, Agitation, Pain, Physiological Parameters
- Trial name
- NCT07794696
- Testing
- Family Video.Participants watched a five-minute video prepared by their family members twice daily on the second and third days of intensive care.
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people
- Sponsor
- Sennur Kula Şahin
Acute Stroke, Psychomotor Agitation
Effect of Virtual Reality on Agitation in Acute Stroke
This randomized controlled, single-blind study evaluates the effect of a Virtual Reality (VR) application on agitation levels and physiological vital signs in patients with acute stroke.
- Trial name
- NCT07787910
- Testing
- Virtual Reality Application, Standard Care (in control arm)
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people
- Sponsor
- Ankara Etlik City Hospital