A Study of L-DOPA for Depression and Slowing in Older Adults
Condition: Major Depressive Disorder; Dysthymia; Depression Not Otherwise Specified; Decreased Processing Speed; Decreased Gait Speed
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Intervention: Levodopa
Intervention MeSH terms: Levodopa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

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.
    

Eligibility 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