Status:
RECRUITING
Dopaminergic Dysfunction in Late-Life Depression
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Emory University
University of Pittsburgh
Conditions:
Late Life Depression
Cognitive Decline
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
Late-Life Depression (LLD), or depression in older adults, often presents with motivational deficits, deficits in performance in cognitive domains including processing speed and executive dysfunction,...
Detailed Description
Late Life Depression (LLD) is a prevalent, disabling, and at times lethal condition for which currently available treatments are often ineffective. No prior study has comprehensively examined dopamine...
Eligibility Criteria
Inclusion
- Age ≥ 60 years
- Diagnostic and Statistical Manual-5 (DSM5) diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depression Not Otherwise Specified (NOS)
- MADRS score ≥ 15
- 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)
- Capable of providing informed consent and adhering to study procedures
Exclusion
- Diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) in the past 12 months
- 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
- Primary neurological disorder, including dementia, stroke, Parkinson's disease, epilepsy, etc
- SBT \> 10
- MADRS suicide item \> 4 or other indication of acute suicidality
- History of inpatient psychiatric hospitalization in the last year;
- 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)
- 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)
- Current or recent (within the past 2 weeks) treatment with antipsychotics or mood stabilizers, or use of antidepressants where washout is not advisable
- History of hypersensitivity, allergy, or intolerance to Carbidopa/levodopa
- Any physical or intellectual disability adversely affecting ability to complete assessments
- Unstable medical illness
- Mobility limiting osteoarthritis of any lower extremity joints, symptomatic lumbar spine disease, or history of joint replacement / spine surgery that limits mobility
- Diagnosis of HIV
- History of significant radioactivity exposure (nuclear medicine studies or occupational exposure).
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04469959
Start Date
February 15 2021
End Date
July 30 2026
Last Update
July 16 2025
Active Locations (2)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
2
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States, 37212