ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 19 of 155 for:    "Huntington disease"

Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03417583
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Jessie Sellers, Vanderbilt University Medical Center

Brief Summary:

Phase A: Recruit 50 patients with HD, and their caregivers, to complete a neuropsychiatric and quality of life battery of scales at baseline. Have these 50 patients complete a formal psychiatric assessment with a psychiatrist within 2 weeks of this clinical battery, and the results of these 2 types of assessments will be compared to establish the level of agreement between clinical rating scales and formal psychiatric assessment.

Phase B: Continue to follow Phase A cohort longitudinally and administer neuropsychiatric and quality of life battery at 6 months, 12 months, and 18 months form baseline. Recruit an additional 50 patients, administer the same neuropsychiatric and quality of life battery at baseline, implement medication and counseling intervention according to a standard of care protocol, and follow up with the same neuropsychiatric and quality of life battery at 6, 12, and 18 months.


Condition or disease Intervention/treatment Phase
Huntington Disease Other: Protocol Intervention Group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Clinical Standard Care Group
These patients will continue to be seen by their regular neurology provider for Huntington's disease. They will not be treated explicitly according to the protocol, though they may be prescribed some of the same medications.
Experimental: Protocol Intervention Group
These participants will transfer their clinical care to the study provider for the duration of the study, and their symptom treatment will be guided by the study protocol.
Other: Protocol Intervention Group
For neuropsychiatric symptoms identified by the clinician, the treatment protocol, based on clinical standard of care, will be implemented. This protocol includes directions for multidisciplinary treatment of 7 neuropsychiatric symptoms: depression, apathy, anxiety, agitation/irritability, obsessive compulsive behaviors, delusions/hallucinations, and sleep dysfunction. These treatment recommendations differ according to symptom but include provision of additional information to patients and caregivers, psychotherapy/counseling, and pharmacotherapeutic treatment options including recommended agents and follow-up schedule.




Primary Outcome Measures :
  1. Change in quality of life- Concern with Death and Dying [ Time Frame: Baseline to 18 months ]
    This is measured using the HDQLIFE Concern with Death and Dying scale, which measures concern with death and dying in Huntington's disease patients. The total score will range from 6 to 30, with higher scores indicating greater concern with death and dying.

  2. Change in quality of life- Meaning and Purpose [ Time Frame: Baseline to 18 months ]
    This is measured using HDQLIFE Meaning and Purpose scale, which measures feelings of meaning and purpose in Huntington's disease patients. The total score will range from 4 to 20, with higher scores indicating greater feelings of meaning and purpose in life.

  3. Change in quality of life- Ability to Participate in Social Roles and Activities [ Time Frame: Baseline to 18 months ]
    This is measured using the NeuroQoL- Ability to Participate in Social Roles and Activities scale, which measures ability of individuals with neurological conditions to participate in social roles and activities. The total score will range from 8 to 40, with higher scores indicating greater ability to participate in social roles and activities.

  4. Change in quality of life- Anxiety [ Time Frame: Baseline to 18 months ]
    This is measured using the NeuroQoL- Anxiety scale, which measures anxiety in individuals with neurological conditions. The total score will range from 8 to 40, with higher scores indicating greater levels of anxiety.

  5. Change in quality of life- Depression [ Time Frame: Baseline to 18 months ]
    This is measured using the NeuroQoL- Depression scale, which measures depression in individuals with neurological conditions. The total score will range from 8 to 40, with higher scores indicating greater levels of depression.

  6. Change in quality of life- Positive Affect and Well-Being [ Time Frame: Baseline to 18 months ]
    This is measured using the NeuroQoL- Positive Affect and Well-Being scale, which measures positive affect and sense of well-being in individuals with neurological conditions. The total score will range from 9 to 45, with higher scores indicating a greater sense of well-being.

  7. Change in quality of life- Satisfaction with Social Roles and Activities [ Time Frame: Baseline to 18 months ]
    This is measured using the NeuroQoL- Satisfaction with Social Roles and Activities scale, which measures satisfaction with social roles and activities in individuals with neurological conditions. The total score will range from 8 to 40, with higher scores indicating greater levels of satisfaction with social roles and activities.

  8. Change in quality of life- Caregiver Strain [ Time Frame: Baseline to 18 months ]
    This is measured using the TBI-CareQoL- Caregiver Strain scale, which measures health related quality of life in caregivers. The total score will range from 6 to 30, with higher scores indicating greater levels of caregiver strain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient participants:

  • Diagnosed with HD, either through genetic testing or neurologist's clinical diagnosis
  • 21 and older will be included, as symptoms of Juvenile HD (in patients 20 years old or less) can present differently
  • Presence of an eligible caregiver who can also participate in the study with them because several of the study measures require caregiver report

Caregivers:

  • 18 years or older
  • A caregiver will be defined as someone who lives with or has at least weekly contact with the HD patient

Exclusion Criteria:

Patient participants:

  • 20 years old or younger
  • Greater than moderate impairment on dementia screening
  • Lack of a caregiver to provide collateral information and complete caregiver assessments will also be excluded

Caregivers:

  • Younger than 18 years old and/or have less than weekly contact with the HD patient
  • Clinical impression of incompetency to answer survey questions as determined by the Jessie Sellers, Nurse Practitioner, or the neurologist caring for the HD patient, then he or she will not be eligible to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417583


Contacts
Contact: Jessie I Sellers, MSN 615-343-4744 jessie.sellers@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Teva Pharmaceuticals USA
Investigators
Study Chair: Shelia H Ridner, PhD Vanderbilt University

Responsible Party: Jessie Sellers, Assistant in Neurology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03417583     History of Changes
Other Study ID Numbers: 172030
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders