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Search / Trial NCT04469959

Dopaminergic Dysfunction in Late-Life Depression

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jul 8, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Antiparkinson Agent Levodopa Elderly Depressive Disorder, Major

ClinConnect Summary

This clinical trial is studying how a medication called carbidopa/levodopa (often used to treat Parkinson's disease) may help improve symptoms in older adults suffering from Late-Life Depression (LLD). Researchers believe that LLD is linked to problems in the brain's dopamine system, which can affect thinking speed, mobility, and overall mood. By enhancing dopamine function, the trial aims to see if it can help patients feel better and improve their ability to move and think clearly.

To participate in the study, individuals must be at least 60 years old and have a diagnosis of depression, along with certain challenges in thinking or walking. Participants should be able to provide informed consent and follow study procedures. Throughout the trial, participants will receive the medication and be monitored for any changes in their mood, thinking, and movement. It's important to note that some individuals with certain medical or psychiatric conditions may not be eligible to join. Overall, this study hopes to offer new insights and potential treatments for older adults dealing with depression.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥ 60 years
  • 2. Diagnostic and Statistical Manual-5 (DSM5) diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depression Not Otherwise Specified (NOS)
  • 3. MADRS score ≥ 15
  • 4. Decreased processing speed (0.5 SD below age-adjusted norms on the WAIS-IV Coding task or Trail Making Test, Part A) or decreased motor speed (gait speed/average walking speed on 15' course ≤ 1m/s, or 0.5 SD below age-, gender- and education-adjusted norms on the grooved pegboard test)
  • 5. Capable of providing informed consent and adhering to study procedures
  • Exclusion Criteria:
  • 1. Diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) in the past 12 months
  • 2. Other psychiatric disorders including a history of psychosis, psychotic disorder, mania, or bipolar disorder. Other comorbid psychiatric disorders are allowable if the depressive disorder diagnosis is considered to be the primary problem
  • 3. Primary neurological disorder, including dementia, stroke, Parkinson's disease, epilepsy, etc
  • 4. SBT \> 10
  • 5. MADRS suicide item \> 4 or other indication of acute suicidality
  • 6. History of inpatient psychiatric hospitalization in the last year;
  • 7. History of suicidal ideation in the last 6 months, operationalized as a 'yes' response to item 4 or 5 in the "Suicidal Ideation" section of the Columbia-Suicide Severity Rating Scale (CSSRS)
  • 8. Any suicidal behavior in the last year (operationalized as a 'yes' response to any item in the "Suicidal Behavior" section of the CSSRS, including actual interrupted, aborted, or preparatory acts)
  • 9. Current or recent (within the past 2 weeks) treatment with antipsychotics or mood stabilizers, or use of antidepressants where washout is not advisable
  • 10. History of hypersensitivity, allergy, or intolerance to Carbidopa/levodopa
  • 11. Any physical or intellectual disability adversely affecting ability to complete assessments
  • 12. Unstable medical illness
  • 13. Mobility limiting osteoarthritis of any lower extremity joints, symptomatic lumbar spine disease, or history of joint replacement / spine surgery that limits mobility
  • 14. Diagnosis of HIV
  • 15. History of significant radioactivity exposure (nuclear medicine studies or occupational exposure).

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Pittsburgh, Pennsylvania, United States

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Warren Taylor, MD,MHSc

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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