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.
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
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
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.
Schizophrenia
A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
The primary objectives of the study is to confirm if the efficacy of IM olanzapine in patients with schizophrenia is greater than IM placebo by comparing changes from baseline to 2 hours post first IM injection of agitation.
- Trial name
- NCT00640510
- Testing
- Rapid Acting Intramuscular Olanzapine, Isotonic sodium chloride solution
- Where
- 11 sites in Japan
- Volunteers
- 34 people
- Sponsor
- Eli Lilly and Company
Agitation in Patients With Dementia of the Alzheimer's Type
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients 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) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National…
- Trial name
- NCT02442765
- Testing
- AVP-786
- Where
- 126 sites in United States, Estonia and 4 more
- Volunteers
- 387 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Study to Assess 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
- NCT04464564
- Testing
- AVP-786
- Where
- 106 sites in United States, Belgium and 11 more
- Volunteers
- 241 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Alzheimer's Disease
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type…
- Trial name
- NCT03594123
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Alzheimer's Disease
Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.
- Trial name
- NCT00843518
- Testing
- LY451395
- Where
- 17 sites in United States
- Volunteers
- 132 people
- Sponsor
- Eli Lilly and Company
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 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 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 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.
Agitation and Aggression in Alzheimer's Disease
A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression
- Trial name
- NCT03118947
- Testing
- Pimavanserin
- Where
- 28 sites in United States, Chile and 3 more
- Volunteers
- 79 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
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.
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.
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.