A Study of L-DOPA for Depression and Slowing in Older Adults

• Status: Completed
• Trial end date: 2018-11-30
• 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 R61/R33 Phased Innovation Award 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
• Treatments: Levodopa

Criteria

Inclusion Criteria:

• Age >59 years

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

• Center for Epidemiological Studies Depression (CES-D) Rating Scale > 9

• Decreased processing speed (defined as 0.5 SD below age-adjusted norms on the Digit Symbol Test) and decreased gait speed (defined as average walking speed over 15' course < 1 m/s)

• Willing and capable of providing informed consent and complying with study procedures

• Prefer not to be treated with a standard treatment for MDD, Dysthymia, or Depression NOS (e.g., antidepressant medication or psychotherapy)

Exclusion Criteria:

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

• History of or current psychosis, psychotic disorder, mania, or bipolar disorder

• Diagnosis of probable Alzheimer's Disease, Vascular Dementia, or PD

• Mini Mental Status Exam (MMSE) < 25

• HRSD ≥ 25 or the presence of significant suicide risk

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

• History of allergy, hypersensitivity reaction, or severe intolerance to LDOPA

• Acute, severe, or unstable medical or neurological illness

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

• Hypotension (SBP<90), hypertension (SBP >150 or DBP > 90), past stroke causing sensory or movement deficits, cardiac arrhythmias, or any other severe or uncontrolled cardiovascular disease

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

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

• Presence of a clinically significant brain abnormality, significant anemia, insulin dependent diabetes, a history of cardiovascular disease, or uncontrolled/untreated risk factors for coronary artery disease