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Agitation,Psychomotor clinical trials

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NCT ID: NCT06217146 Completed - Alzheimer Disease Clinical Trials

A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.

Start date: October 12, 2022
Phase: N/A
Study type: Interventional

This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's balanced T3:C3 oil, a medical cannabis oil extracted from MediCane's balanced proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of care (SoC), in reducing agitation and disruptive behaviors in subjects with dementia including probable AD.

NCT ID: NCT06041646 Completed - Schizophrenia Clinical Trials

Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder

Start date: October 12, 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05272501 Completed - Dementia Clinical Trials

CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial

CADEM
Start date: October 4, 2021
Phase: N/A
Study type: Interventional

Dementia is an increasing health challenge among elderly citizens in Denmark. An estimated 87,000 Danes live with dementia, and this number is expected to increase to 130,000 in 2030. Psychiatric symptoms and behavioral changes decrease quality of life for patients and their spouses and is a challenge for caretakers. Behavior changes include agitation which can be divided in four sub-groups: 1) physical aggression, 2) physical non-aggression, 3) verbal aggression, and 4) verbal non-aggression. Pharmaceutical management of behavioral changes is common and may be associated with negative side-effects including drowsiness and falls. Though non-pharmaceutical interventions such as music, massage and social activities have been recommended the underlying evidence is limited. In this randomized feasibility trial, we will investigate the feasibility and acceptability of therapeutic touch aiming to reduce agitated behavior in people living with dementia in a nursing home that specializes in the care of people living with severe dementia. The success criteria of this randomized feasibility trial are as follows: 1. Nursing home residents can be recruited and accept the treatment 'CAlming Touch for People with Agitation or Other Behavioral Symptoms of DEMentia' (CADEM) and complete the feasibility project's test protocol. 2. The treatment concept, which involves the nursing staff in charge of the follow-up treatment, can be implemented in practice. 3. The treatment (CADEM) shows a tendency towards less restless and aggressive behavior for demented citizens evaluated based on a validated measuring tool.

NCT ID: NCT04797715 Completed - Alzheimer Disease Clinical Trials

Assessing Clinical Outcomes in Alzheimer's Disease Agitation

ACCORD
Start date: December 31, 2020
Phase: Phase 3
Study type: Interventional

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 with Alzheimer's disease.

NCT ID: NCT04514432 Completed - Clinical trials for Agitation,Psychomotor

Mindful Melody: Feasibility of Implementing Music Listening on an Inpatient Psychiatric Unit and Its Relation to the Use of As Needed Medications for Acute Agitation

Start date: August 16, 2018
Phase:
Study type: Observational

In this quality improvement project, our objectives were to assess the feasibility and effectiveness of using music as an adjunct to or replacement of pharmacological interventions for patient agitation on an inpatient psychiatric unit. We hypothesized that music availability would help to reduce agitation and reduce the amount of as-needed medications used for cases of patient agitation.

NCT ID: NCT04276883 Completed - Bipolar Disorder Clinical Trials

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

SERENITY II
Start date: February 24, 2020
Phase: Phase 3
Study type: Interventional

This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.

NCT ID: NCT04251910 Completed - Dementia Clinical Trials

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

TRANQUILITY
Start date: December 27, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

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 and older) males and females with acute agitation associated with dementia. Evaluation of 3 doses are planned.

NCT ID: NCT04053426 Completed - Clinical trials for Agitation,Psychomotor

Agitation Follow up After Introduction of a New Patient Care Algorithm

SARA
Start date: July 19, 2018
Phase:
Study type: Observational

Agitation in the intensive care unit is motor hyperactivity. It is frequent (b/w 30% to 70%) and has multiple causes: pain, medical reason, delirium, medication, etc. It can be a source of complication, for the patient, and equipment pullout. International recommendations state that the agitation should be taken care of with standardized protocols to improve patient care.

NCT ID: NCT03226522 Completed - Alzheimer Disease Clinical Trials

Addressing Dementia Via Agitation-Centered Evaluation

ADVANCE
Start date: July 13, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT03211897 Completed - Clinical trials for Agitation,Psychomotor

Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation

MOHZA
Start date: June 15, 2017
Phase: N/A
Study type: Observational

The goal of this research investigation is to conduct a prospective observational study of the comparative efficacy of haloperidol versus olanzapine versus midazolam versus ziprasidone for the treatment of acute undifferentiated agitation in the emergency department.