Clinical trials: Psychomotor Agitation
Psychomotor Agitation, Acute Disease
IMPACT: A Study to Explore the Efficacy and Safety of Paliperidone ER in Patients With Acute Agitation
This study will investigate the effect of paliperidone ER (in combination with or without benzodiazepines) in patients presenting with symptoms of agitation and/or aggression in the context of psychosis, and will generate data…
- Trial name
- NCT01050478
- Testing
- Paliperidone ER, Benzodiazepine
- Where
- 14 sites in Belgium
- Volunteers
- 56 people
- Sponsor
- Janssen Cilag N.V./S.A.
Alzheimer 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 (ADAGIO-1)
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
- NCT07011732
- Testing
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule
- Where
- 162 sites in United States, Argentina and 13 more
- Volunteers
- 426 people
- Sponsor
- Bristol-Myers Squibb
Agitation in Patients With Dementia of the Alzheimer's Type
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with…
- Trial name
- NCT04408755
- Testing
- AVP-786
- Where
- 95 sites in United States, Bulgaria and 9 more
- Volunteers
- 184 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation Associated With Dementia of the Alzheimer's Type
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the…
- Trial name
- NCT03620981
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 410 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Alzheimer's Disease
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease
- Trial name
- NCT01735630
- Testing
- ELND005
- Where
- 70 sites in United States, Canada and 2 more
- Volunteers
- 350 people
- Sponsor
- OPKO Health, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
- Trial name
- NCT02446132
- Testing
- AVP-786
- Where
- 227 sites in United States, Bulgaria and 8 more
- Volunteers
- 1,197 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated…
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
- Trial name
- ACCORD (NCT04797715)
- Testing
- AXS-05
- Where
- 63 sites in United States, Canada
- Volunteers
- 178 people
- Sponsor
- Axsome Therapeutics, Inc.
Schizophrenia
Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia
The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.
- Trial name
- NCT00954122
- Testing
- Quetiapine XR (Seroquel XR)
- Where
- 2 sites in Malaysia
- Volunteers
- 35 people
- Sponsor
- AstraZeneca
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.
Agitation Associated With, Alzheimer's Disease
Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type
- Conditions
- Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder
- Trial name
- NCT01922258
- Testing
- Brexpiprazole, OPC-34712
- Where
- 70 sites in United States, Bulgaria and 7 more
- Volunteers
- 270 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Alzheimer's Disease, Vascular Dementia
Seroquel- Agitation Associated With Dementia
The purpose of this study is to determine how safe and effective Seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation symptoms in nursing home or…
- Trial name
- NCT00621647
- Testing
- Quetiapine Fumarate
- Volunteers
- 333 people
- Sponsor
- AstraZeneca
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, Alzheimer Disease
Feasibility of Passive Data Collection in Dementia Subjects With Agitation
This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, physiological, and audio data…
- Conditions
- Dementia, Alzheimer Disease, Vascular Dementia, Frontotemporal Dementia
- Trial name
- NCT04413851
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- HealthMode Inc.
Agitation,Psychomotor, Disruptive Behavior
A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.
This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's medical cannabis oil extracted from MediCane's proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of…
- Conditions
- Agitation,Psychomotor, Disruptive Behavior, Dementia, Alzheimer Disease
- Trial name
- NCT06217146
- Testing
- Medical Cannabis
- Where
- 3 sites in Israel
- Volunteers
- 24 people
- Sponsor
- M. H MediCane Ltd.
Dementia
Study of Depakote for Behavioral and Psychological Symptoms in Dementia
This prospective, naturalistic, open label study will test the hypothesis that Depakote is correlated with a reduction in elevated Cohen-Mansfield Agitation Index (CMAI) verbal and physical agitation and aggression scales over a…
- Trial name
- NCT00197834
- Testing
- Depakote
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hearthstone Alzheimer Care
Schizophrenia
IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)
To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia
- Trial name
- NCT00136994
- Testing
- Ziprasidone
- Where
- 34 sites in Italy
- Volunteers
- 160 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Alzheimer's Disease
Memesto Wearable Repetitive Message and Music Therapy Device Music Therapy Device That Senses and Reduces Agitation in People With AD,
This is a 12-week proof-of-concept study to evaluate the efficacy of Memesto in reducing agitation in persons with Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) currently living in a residential care…
- Trial name
- AWARD (NCT06596278)
- Testing
- Memesto
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Edgewater Safety Systems, Inc.
Alzheimer's Disease
Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Alzheimer's Disease
This study evaluates the effect of ORM-12741 on agitation/aggression symptoms in Alzheimer's disease. Two thirds of the patients will receive ORM-12741 and one third will receive placebo.
- Trial name
- Nebula (NCT02471196)
- Testing
- ORM-12741
- Where
- Finland
- Volunteers
- 308 people
- Sponsor
- Orion Corporation, Orion Pharma
Agitation and Aggression in Alzheimer's Disease
Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment
- Trial name
- NCT02992132
- Testing
- Pimavanserin 34 mg, Pimavanserin 20 mg
- Where
- 56 sites in United States, Chile and 3 more
- Volunteers
- 111 people
- Sponsor
- ACADIA Pharmaceuticals Inc.