Clinical trials: Agitation
Agitation, Dementia
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
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 28 doses within a 12-week treatment period.
- Trial name
- NCT05271552
- Testing
- BXCL501
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation, Dementia
An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation…
- Trial name
- NCT05276830
- Testing
- BXCL501
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation, Delirium
Study of BXCL501 In Agitation Associated With Delirium in ICU Patients
This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD) that will safely and effectively reduce agitation associated with delirium in ICU patients.
- Trial name
- NCT05313386
- Testing
- BXCL501
- Where
- United States
- Sponsor
- BioXcel Therapeutics Inc
Bipolar Disorder, Schizophrenia
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Conditions
- Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder
- Trial name
- NCT06041646
- Testing
- Sublingual film containing Igalmi
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BioXcel Therapeutics Inc
Alzheimer Disease
Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease
Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients.
- Trial name
- NCT05477862
- Testing
- Clinically Designed Improvisatory Music
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Agitation,Psychomotor, Bipolar I Disorder
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform…
- Conditions
- Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia
- Trial name
- NCT05658510
- Testing
- BXCL501
- Where
- 24 sites in United States
- Volunteers
- 452 people
- Sponsor
- BioXcel Therapeutics Inc
Neurodegenerative Diseases, Behavioral Symptoms
Impact of Harp Therapy on Behavioral Disorders in Nursing Home Residents With Neurodegenerative Disease (ARPE)
The ARPE study looked at whether weekly harp therapy sessions could reduce behavioral problems in older adults living in memory care units of a nursing home (EHPAD).
- Conditions
- Neurodegenerative Diseases, Behavioral Symptoms, Dementia, Agitation
- Trial name
- ARPE (NCT07748013)
- Testing
- Harp therapy (receptive music therapy)
- Where
- France
- Volunteers
- 25 people
- Sponsor
- LNA SANTE
Agitation, Postoperative Agitation
Effect of Daily Screen Time on Postoperative Emergence Delirium in Children Aged 2-11 Years
This prospective observational study aims to evaluate the association between daily screen exposure duration and postoperative emergence delirium in children aged 2 to 11 years undergoing elective lower abdominal surgery.
- Trial name
- NCT07552896
- Testing
- Daily Screen Exposure Duration
- Where
- Turkey (Türkiye)
- Volunteers
- 288 people
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Emergence Agitation, General Anesthesia
Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery
Emergence agitation (EA) is a common complication during recovery from sevoflurane anesthesia, particularly after nasal surgery.
- Conditions
- Emergence Agitation, General Anesthesia, Nasal Surgical Procedures
- Trial name
- NCT07740655
- Testing
- Remimazolam
- Where
- South Korea
- Volunteers
- 138 people
- Sponsor
- Jeju National University School of Medicine
Alzheimer Dementia, Agitation,Psychomotor
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia…
- Trial name
- ECT-AD (NCT03926520)
- Testing
- Electroconvulsive Therapy (ECT)
- Where
- 5 sites in United States
- Volunteers
- 41 people
- Sponsor
- Brent Forester
Frontotemporal Dementia, Frontotemporal Dementia, Behavioral Variant
Nabilone for Agitation in Frontotemporal Dementia
The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and…
- Conditions
- Frontotemporal Dementia, Frontotemporal Dementia, Behavioral Variant, Primary Progressive Aphasia, bvFTD
- Trial name
- Nabilone-FTD (NCT05742698)
- Testing
- Nabilone
- Where
- 7 sites in Canada
- Volunteers
- 3 people
- Sponsor
- Simon Ducharme, MD
Dementia, Cognitive Dysfunction
Protocolized Receptive Music Intervention to Reduce Care Refusal in Nursing Home Residents With Major Neurocognitive Disorders
The goal of this randomized study is to find out whether using a structured, protocolized music program (MUSIC CARE©) during daily hygiene care can reduce care refusal in older adults with dementia (memory and thinking…
- Conditions
- Dementia, Cognitive Dysfunction, Psychomotor Agitation, Burnout, Professional
- Trial name
- OPPOZIC' (NCT07730957)
- Testing
- Receptive music therapy, Standard Nursing Home Care
- Where
- 12 sites in France
- Volunteers
- 60 people
- Sponsor
- LNA SANTE
Sleep Disturbances, Depression
Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia
- Trial name
- NCT01816152
- Testing
- High Active intervention, Inactive intervention, Mid Level Active Intervention
- Where
- 2 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Post Tonsillectomy Emergence Agitation
Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are: Does melatonin decrease emergence agitation in pediatric post…
- Trial name
- NCT07375342
- Testing
- Melatonin
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Benha University
Hip Osteoarthritis, Hip Arthroplasty Replacement
Virtual Reality for Intraoperative Anxiolysis and Postoperative Agitation in Elderely Hip Arthroplasty Patients
This study evaluates the effectiveness of Virtual Reality (VR) as a non-pharmacological intervention to reduce intraoperative anxiety and postoperative agitation in elderly patients undergoing elective hip arthroplasty under…
- Conditions
- Hip Osteoarthritis, Hip Arthroplasty Replacement, Emergence Delirium, Anesthesia, Emergence Agitation
- Trial name
- VR (NCT07705451)
- Testing
- immersive virtual reality, standard sedation
- Volunteers
- 40 people
- Sponsor
- Menoufia University
Critically Ill, Intensive Care Unit Delirium
Physical Restraints in Intensive Care Unit Patients
The use of physical restraints is common practice in Intensive Care Units (ICU). This medically prescribed procedure requires full attention of medical and paramedical teams for its implementation, monitoring and ending, as a…
- Conditions
- Critically Ill, Intensive Care Unit Delirium, Delirium Confusional State, Agitation,Psychomotor
- Trial name
- ARBORéa (NCT04957238)
- Testing
- ARBORea decision-making tool
- Where
- 19 sites in France
- Volunteers
- 4,000 people
- Sponsor
- University Hospital, Clermont-Ferrand
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study
The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
- Trial name
- NCT06736509
- Testing
- AXS-05 (dextromethorphan-bupropion)
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 139 people
- Sponsor
- Axsome Therapeutics, Inc.
Lumbar Disc Herniation, Emergence Agitation
Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery
In this retrospective study, the effect of intraoperative magnesium sulfate infusion on the incidence of postoperative emergence agitation was evaluated in adult patients who underwent elective lumbar microdiscectomy under…
- Conditions
- Lumbar Disc Herniation, Emergence Agitation, Magnesium Sulfate
- Trial name
- NCT07139847
- Testing
- Magnesium Sulfate Infusion, 0.9% Saline Infusion
- Volunteers
- 70 people
- Sponsor
- Ondokuz Mayıs University
General Anesthetics，Emergence Agitation
Advanced Analgesia on the Quality of Recovery After General Anesthesia in Elderly Patients
Recovery period of general anesthesia refers to the period from the end of anesthesia infusion to recovery of the patient after the operation.
- Trial name
- NCT05769530
- Testing
- Nalbuphine，dexmedetomidine
- Where
- 2 sites in China
- Volunteers
- 360 people
- Sponsor
- Lili Jia
Chronic Rhinosinusitis (CRS), Emergence Agitation
Trans-nasal Sphenopalatine Ganglion Block for Prevention of Emergence Agitation Following Functional Endoscopic Sinus Surgery
This randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic…
- Trial name
- SPGB-EA (NCT07645521)
- Testing
- Bilateral Trans-nasal Sphenopalatine Ganglion Block
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Mansoura University