L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Individuals with Late Life Depression (LLD) often have cognitive problems, particularly problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Our group and others have shown that decreased thinking speed is the central cause of functional problems in patients with LLD. Similarly, decreased walking speed is associated with depression and carries additional risk for falls, hospitalization, and death. Available evidence suggests that declining functionality in the brain's dopamine system contributes to age-related cognitive and motor slowing. The central hypothesis of this study is that by enhancing dopamine functioning in the brain and improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms in older adults.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

Inclusion Criteria:

1. Aged 60 years and older

2. DSM 5 non-psychotic Major Depressive Disorder, Dysthymia, or Depression Not Otherwise Specified

3. Hamilton Rating Scale for Depression (HRSD) > 15

4. Decreased processing speed (defined as performance > 0.5SD below age-adjusted norms on Digit Symbol Substitution Test or Trail Making Test Part A) OR decreased gait speed (defined as average walking speed over 15' course < 1m/s)

5. Willing to and capable of providing informed consent and complying with study procedures

6. Alternative standard treatments for MDD, Dysthymia, or Depression NOS (e.g., antidepressant medication or psychotherapy) have been discussed and the individual agrees to be involved in an experimental treatment.

Exclusion Criteria:

1. Diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) within the past 12 months.

2. History of or current psychosis, psychotic disorder, mania, or bipolar disorder

3. Diagnosis of probable Alzheimer's Disease, Vascular Dementia, or Parkinson's Disease (PD)

4. Mini Mental Status Exam (MMSE) < 25

5. HRSD ≥ 28; HRSD suicide item > 2 or the presence of significant suicide risk as judged by clinician or Clinical Global Impressions (CGI)-Severity score of 7 at baseline.

6. Current or recent (within the past 4 weeks) treatment with antidepressants, antipsychotics, dopaminergic agents, or mood stabilizers.

7. History of allergy, hypersensitivity reaction, or severe intolerance to L-DOPA

8. Acute, severe, or unstable medical or neurological illness

9. Mobility limiting osteoarthritis of any lower extremity joints, symptomatic lumbar spine disease, mobility limiting history of joint replacement surgery, or history of spine surgery

FOR SUBJECTS RECEIVING PET/MRI SCANS ONLY:

10. Having contraindication to MRI scanning (such as metal in body) or unable to tolerate the scanning procedures

11. History of significant radioactivity exposure (nuclear medicine studies or occupational exposure)