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

NCT03417583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-15

No results posted yet for this study

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.

Conditions

  • Huntington Disease

Interventions

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.

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • David Isaacs · Vanderbilt University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2023-01-10
Completion
2023-10-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03417583 on ClinicalTrials.gov