Clinical trials: Psychomotor Agitation
Alzheimer's Disease
A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
- Trial name
- NCT01766336
- Testing
- Group 1 ELND005, Group 2 ELND005
- Where
- 46 sites in United States, Canada and 2 more
- Volunteers
- 296 people
- Sponsor
- OPKO Health, Inc.
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
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
Agitation Associated With Dementia of the Alzheimer's Type
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy…
- Trial name
- NCT03724942
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 164 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Neurobehavioral Disinhibition
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury…
- Trial name
- NCT03095066
- Testing
- AVP-786-28, AVP-786-42.63
- Where
- 54 sites in United States
- Volunteers
- 168 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Alzheimer Disease
Memesto Wearable Device for Persons With Dementia
An estimated 70% of the 7.2+ million people in the U.S. with Alzheimer's Disease and Alzheimer's Disease-Related Dementias experience agitation, characterized by poorly organized and purposeless psychomotor activity that…
- Trial name
- NCT05153161
- Testing
- Memesto
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Edgewater Safety Systems, Inc.
Agitation Associated With Bipolar Disorder, Agitation,Psychomotor
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder.
- Conditions
- Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
- Trial name
- SERENITY II (NCT04276883)
- Testing
- Sublingual film containing Dexmedetomidine (BXCL501)
- Where
- 15 sites in United States
- Volunteers
- 380 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
Agitation
Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with…
- Trial name
- NCT02525991
- Testing
- Staccato® Delivery System Loxapine (ADASUVE®)
- Where
- Spain
- Volunteers
- 323 people
- Sponsor
- Ferrer Internacional S.A.
Schizophrenia, Schizoaffective Disorder
Study on the Safety and Effectiveness of Risperidone Treatment of Acute Psychotic Patients
The purpose of this study was to evaluate the safety of risperidone treatment in acute psychotic patients that require an admission into emergency department.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- Trial name
- NCT00515489
- Testing
- Risperidone
- Volunteers
- 1,882 people
- Sponsor
- Janssen-Cilag, S.A.
Agitation Associated With Alzheimer's Dementia
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.
- Trial name
- NCT06651567
- Testing
- ITI-1284
- Where
- 71 sites in United States, Bulgaria and 6 more
- Volunteers
- 320 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Acute Agitation
A Study of Olanzapine in Patients With Acute Agitation
The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.
- Trial name
- NCT05803642
- Testing
- Olanzapine, Haloperidol
- Volunteers
- 318 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Mild to Moderate Dementia
The Effect of Auditory Interventions on Anxiety and Agitation in People With Dementia
The greying of the world is leading to a rapid acceleration in both the healthcare costs and caregiver burden that are associated with dementia.
- Trial name
- NCT05844241
- Testing
- Music and Theta Auditory Beat Stimulation, Audiobooks
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Lucid, Inc.
Alzheimer's Disease, Healthy Elderly
Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease
This study consists of 2 parts, Part A and Part B. Part A is a single center, randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of NMRA-323511 among…
- Trial name
- NCT06546995
- Testing
- NMRA-323511
- Where
- 26 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Neumora Therapeutics, Inc.
Dementia, Alzheimer's Disease
Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
The purpose of this trial is to test the safety \& tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.
- Trial name
- NCT00095719
- Testing
- Aripiprazole
- Where
- 14 sites in United States
- Volunteers
- 125 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Agitation
Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INP105, which is an investigational drug-device combination product comprised of the drug component OLZ administered by a…
- Trial name
- SNAP101 (NCT03624322)
- Testing
- Zyprexa IM, Zydis, INP105
- Where
- Australia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Impel Pharmaceuticals
Agitation in Participants With Dementia of the Alzheimer's Type
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National…
- Trial name
- NCT02442778
- Testing
- AVP-786-18, AVP-786-28, AVP-786-42.63
- Where
- 83 sites in United States, Canada
- Volunteers
- 522 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Agitation in Dementia, Including Alzheimer's Disease
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including…
- Trial name
- NCT02817906
- Testing
- ITI-007
- Where
- 26 sites in United States
- Volunteers
- 177 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
- Trial name
- ACCORD-2 (NCT04947553)
- Testing
- AXS-05 (dextromethorphan-bupropion)
- Where
- 47 sites in United States, Canada and 1 more
- Volunteers
- 456 people
- Sponsor
- Axsome Therapeutics, Inc.