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1/2-Dopaminergic Dysfunction in Late-Life Depression (The D3 Study)

NCT04493320 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-05-22

Study results available
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Summary

Growing evidence suggests that dopamine contributes to key cognitive, emotional, and motor functions across the lifespan. In Late-Life Depression (LLD), dysfunction in these areas is common, predicts poor outcomes, and manifests as difficulties in motivation and effort along with cognitive and gait impairment. While studies of dopamine function in early and midlife depression primarily focus on individuals' ability to feel pleasure and respond to rewards, they often exclude the cognitive and physical function domains relevant for older adults despite a recognized decline in dopamine function with normal aging. The objectives of this collaborative R01 proposal between Columbia University/New York State Psychiatric Institute and Vanderbilt University Medical Center are to: 1) characterize dopaminergic dysfunction in LLD across cognitive, emotional, and motor domains at several levels of analysis (cellular Positron Emission Tomography \[PET\], circuit Magnetic Resonance Imaging \[MRI\], and behavioral / self-report); and 2) examine the responsivity of dopamine-related circuits and behavior to stimulation with carbidopa/levodopa (L-DOPA).

Conditions

Interventions

DRUG

Carbidopa/levodopa

150-450mg carbidopa/levodopa 3 times daily

DRUG

Placebo

Carbidopa/levodopa-matched placebo tablet 3 times daily

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Bret R Rutherford, MD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2021-10-27
Completion
2021-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases
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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 NCT04493320 on ClinicalTrials.gov