A Study of L-DOPA for Depression and Slowing in Older Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 2/10/2019 |
| Start Date: | April 2016 |
| End Date: | March 2021 |
| Contact: | Veronika S Bailey, MA |
| Email: | veronika.bailey@nyspi.columbia.edu |
| Phone: | 646-884-8655 |
This study will elucidate the neurobiology of slowing and LLD, identify a novel therapeutic
target for depression, and contribute to the development of personalized treatment regimens
for LLD. The multimodal neuroimaging methods detailed in this application will provide
information about the neurobiology of aging-associated slowing and LLD at molecular,
structural, and functional levels of analysis. These data will fill a crucial gap in our
knowledge regarding what are the physiologic and functional consequences of dopamine
depletion occurring across the lifespan in individuals without PD. Results from this project
also will allow us to evaluate a novel therapeutic approach to LLD, which could have large
public health ramifications given the prevalence, frequent treatment resistance, and
chronicity characteristic of LLD. Even apart from patients with LLD, cognitive and motor
slowing exact a large public health burden in terms of impaired functioning and increased
morbidity and mortality, and this burden will only grow as the population ages. It is
critical to develop treatments capable of altering the negative health trajectories
associated with slowing in order to help older adults maintain independent functioning and
live longer with an increased quality of life. Finally, while PET and MRI may prove critical
to understand the neurobiology of slowing and LLD, their invasiveness and expense limit their
roles in informing treatment decisions in clinical practice settings. For this reason the
investigators are also assessing the influence of genetic moderators such as interleukin-6
(IL-6) and catechol-O-methyl-transferase (COMT) genotype on baseline dopamine functioning and
response to L-DOPA. This may facilitate the identification of both high-risk individuals and
those most likely to benefit from treatment interventions.
target for depression, and contribute to the development of personalized treatment regimens
for LLD. The multimodal neuroimaging methods detailed in this application will provide
information about the neurobiology of aging-associated slowing and LLD at molecular,
structural, and functional levels of analysis. These data will fill a crucial gap in our
knowledge regarding what are the physiologic and functional consequences of dopamine
depletion occurring across the lifespan in individuals without PD. Results from this project
also will allow us to evaluate a novel therapeutic approach to LLD, which could have large
public health ramifications given the prevalence, frequent treatment resistance, and
chronicity characteristic of LLD. Even apart from patients with LLD, cognitive and motor
slowing exact a large public health burden in terms of impaired functioning and increased
morbidity and mortality, and this burden will only grow as the population ages. It is
critical to develop treatments capable of altering the negative health trajectories
associated with slowing in order to help older adults maintain independent functioning and
live longer with an increased quality of life. Finally, while PET and MRI may prove critical
to understand the neurobiology of slowing and LLD, their invasiveness and expense limit their
roles in informing treatment decisions in clinical practice settings. For this reason the
investigators are also assessing the influence of genetic moderators such as interleukin-6
(IL-6) and catechol-O-methyl-transferase (COMT) genotype on baseline dopamine functioning and
response to L-DOPA. This may facilitate the identification of both high-risk individuals and
those most likely to benefit from treatment interventions.
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
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Bret Rutherford, MD
Phone: 646-774-8655
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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