Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT04493320
Eligibility Criteria:
Inclusion Criteria:
Depressed Subjects:
1. 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)
2. Diagnosis and Statistical Manual (DSM-5) diagnosis of Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD)
3. Montgomery Asberg Depression Rating Scale Score (MADRS) \>=15
4. Decreased processing speed or decreased gait speed
5. Capable of providing informed consent and complying with study procedures
6. Alternative standard treatments for MDD or PDD have been discussed and the individual agrees to be involved in an experimental treatment
Psychiatrically Healthy Elders:
1. Age 60 years or older years old
2. MADRS \< 8
3. Capable of providing informed consent and complying with study procedures
Exclusion Criteria:
Depressed Subjects:
1. Diagnosis of Substance Use Disorder (excluding Tobacco Use Disorder) in the past 12 months
2. History of psychosis (except brief psychosis associated with transient medical conditions \[e.g., delirium, urinary tract infection, etc\], psychotic disorder, mania, or bipolar disorder.
3. Primary neurological disorder, including dementia, stroke, Parkinson's disease, or epilepsy.
4. Mini Mental State Examination (MMSE) \< 24
5. MADRS suicide item \>4 or other indication of acute suicidality
6. Current or recent (within the past 2 weeks) treatment with antidepressants, antipsychotics, or mood stabilizers
7. History of hypersensitivity, allergy, or intolerance to L-DOPA
8. Any physical or intellectual disability adversely affecting ability to complete assessments.
9. Acute, severe, or unstable medical illness
10. Mobility limiting osteoarthritis of any lower extremity joints, symptomatic lumbar spine disease, or history of joint replacement or spine surgery that limits mobility
11. 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.)
12. History of significant radioactivity exposure (nuclear medicine studies or occupational exposure)
13. 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:
1. Any personal history of DSM-5 disorder
2. Family history of MDD in first-degree relative
3. Plus, Exclusion criteria 8-12 above
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04493320
Study Brief:
Protocol Section:
NCT04493320