Clinical trials: Agitated Behaviour
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
Addressing Dementia Via Agitation-Centered Evaluation
This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
- Trial name
- ADVANCE (NCT03226522)
- Testing
- AXS-05, Bupropion
- Where
- 78 sites in United States, Australia
- Volunteers
- 366 people
- Sponsor
- Axsome Therapeutics, 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
Schizophrenia, Psychotic Disorders
Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone
To assess the effect of risperidone 2 mg daily (QD) on the differential sensitivity of 2 spatial working memory tests (the GMLT and MDR) in non-agitated, drug-naive patients suffering from first-episode…
- Trial name
- NCT00174200
- Testing
- Risperidone 2 mg
- Where
- 3 sites in Canada, Russia
- Volunteers
- 20 people
- Sponsor
- Pfizer
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.
Schizophrenia
A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia
To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated Patients with Schizophrenia
- Trial name
- NCT00316238
- Testing
- olanzapine-RAIM
- Where
- 15 sites in Japan
- Volunteers
- 160 people
- Sponsor
- Eli Lilly and Company
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
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
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.
Agitation in Patients With Dementia of the Alzheimer's Type
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
- Trial name
- NCT03393520
- Testing
- AVP-786
- Where
- 211 sites in United States, Australia and 9 more
- Volunteers
- 601 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia
- Trial name
- NCT00723606
- Testing
- Intramuscular ziprasidone mesylate, Intramuscular haloperidol
- Where
- 9 sites in China
- Volunteers
- 376 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Agitation,Psychomotor, Dementia
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years…
- Trial name
- TRANQUILITY (NCT04251910)
- Testing
- Sublingual film containing Dexmedetomidine
- Where
- 5 sites in United States
- Volunteers
- 100 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, Alzheimer's Disease
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).
- Trial name
- NCT01584440
- Testing
- AVP-923-20, AVP-923-30
- Where
- 44 sites in United States
- Volunteers
- 220 people
- Sponsor
- Avanir Pharmaceuticals
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
Restless Legs Syndrome, Depression
Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment
- Trial name
- NCT00356096
- Testing
- pramipexole
- Where
- 54 sites in Finland, France and 7 more
- Volunteers
- 404 people
- Sponsor
- Boehringer Ingelheim
Agitation in Adolescents and Young Adults With ASD
INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD
This is a Phase 2a, proof-of concept, 2-way, 2-period crossover, double-blind study to evaluate the safety and efficacy of INP105 as an acute treatment versus placebo in adolescents and young adults with autism spectrum disorder…
- Trial name
- CALM 201 (NCT05163717)
- Testing
- INP105
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Impel Pharmaceuticals
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
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
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's Disease
An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease
About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease.
- Trial name
- NCT00097916
- Testing
- memantine HCl
- Where
- 9 sites in United States
- Volunteers
- 34 people
- Sponsor
- Forest Laboratories