Status:
TERMINATED
1/2-Dopaminergic Dysfunction in Late-Life Depression (The D3 Study)
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Vanderbilt University Medical Center
Conditions:
Depression
Cognitive Impairment
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Supported by pilot data, this project builds on past work demonstrating that dopamine function declines with aging, that dopaminergic dysfunction contributes to deficits in behavior, and that L-DOPA a...
Eligibility Criteria
Inclusion
- Depressed Subjects:
- Age 60 years or older (female subjects will be post-menopausal by virtue of their age, but last menstrual period month and year will be documented in the study database)
- Diagnosis and Statistical Manual (DSM-5) diagnosis of Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD)
- Montgomery Asberg Depression Rating Scale Score (MADRS) \>=15
- Decreased processing speed or decreased gait speed
- Capable of providing informed consent and complying with study procedures
- Alternative standard treatments for MDD or PDD have been discussed and the individual agrees to be involved in an experimental treatment
- Psychiatrically Healthy Elders:
- Age 60 years or older years old
- MADRS \< 8
- Capable of providing informed consent and complying with study procedures
Exclusion
- Depressed Subjects:
- Diagnosis of Substance Use Disorder (excluding Tobacco Use Disorder) in the past 12 months
- History of psychosis (except brief psychosis associated with transient medical conditions \[e.g., delirium, urinary tract infection, etc\], psychotic disorder, mania, or bipolar disorder.
- Primary neurological disorder, including dementia, stroke, Parkinson's disease, or epilepsy.
- Mini Mental State Examination (MMSE) \< 24
- MADRS suicide item \>4 or other indication of acute suicidality
- Current or recent (within the past 2 weeks) treatment with antidepressants, antipsychotics, or mood stabilizers
- History of hypersensitivity, allergy, or intolerance to L-DOPA
- Any physical or intellectual disability adversely affecting ability to complete assessments.
- Acute, severe, or unstable medical illness
- Mobility limiting osteoarthritis of any lower extremity joints, symptomatic lumbar spine disease, or history of joint replacement or spine surgery that limits mobility
- Contraindication to MRI scanning (Metal implants, pacemaker, metal prostheses, metal orthodontic appliances in the body unless there is confirmation that the substance is MRI compatible.)
- History of significant radioactivity exposure (nuclear medicine studies or occupational exposure)
- Has a medical condition managed with medication and/or device and the managing physician considers the condition and/or its management a contraindication to the research use of L-DOPA in this participant
- Psychiatrically Healthy Elders:
- Any personal history of DSM-5 disorder
- Family history of MDD in first-degree relative
- Plus, Exclusion criteria 8-12 above
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04493320
Start Date
February 10 2021
End Date
October 27 2021
Last Update
May 22 2023
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032