Clinical trials: Agitation,Psychomotor
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
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
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.
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.
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.
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
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.
Akathisia, Drug-Induced, Dyskinesia, Drug-Induced
Study of Preladenant for the Treatment of Antipsychotic Induced Movement Disorders in Participants With Schizophrenia (Study P04628)
This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder.
- Conditions
- Akathisia, Drug-Induced, Dyskinesia, Drug-Induced, Parkinsonian Disorders
- Trial name
- NCT00686699
- Testing
- Preladenant
- Volunteers
- 11 people
- Sponsor
- Merck Sharp & Dohme LLC
Akathisia, Drug-Induced, Antipsychotic Agents
Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)
This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.
- Conditions
- Akathisia, Drug-Induced, Antipsychotic Agents, Movement Disorders
- Trial name
- NCT00693472
- Testing
- Preladenant, Anticholinergic agents or propanolol, Haloperidol
- Volunteers
- 46 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
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 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.
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.
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
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 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.
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.
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.
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
Nervousness, Restlessness
Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness
Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Each patient is treated with NPB. No placebo group is established.
- Conditions
- Nervousness, Restlessness, Depression (Agitated), Affective Disorders
- Trial name
- NCT01125579
- Where
- Germany
- Volunteers
- 115 people
- Sponsor
- Pascoe Pharmazeutische Praeparate GmbH