Status:
TERMINATED
L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Dysthymia
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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. Ou...
Detailed Description
Enrolled participants were aged 60 and older with (1) a DSM 5 depressive disorder, (2) significant depressive symptoms, and (3) decreased thinking or walking speed will receive 8 weeks of treatment wi...
Eligibility Criteria
Inclusion
- Aged 60 years and older
- DSM 5 non-psychotic Major Depressive Disorder, Dysthymia, or Depression Not Otherwise Specified
- Hamilton Rating Scale for Depression (HRSD) \> 15
- 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)
- Willing to and capable of providing informed consent and complying with study procedures
- 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
- 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 Parkinson's Disease (PD)
- Mini Mental Status Exam (MMSE) \< 25
- 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.
- 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 L-DOPA
- Acute, severe, or unstable medical or neurological illness
- 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:
- 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)
Key Trial Info
Start Date :
January 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03761030
Start Date
January 9 2019
End Date
September 8 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