Phase 4
N=47
A Study of L-DOPA for Depression and Slowing in Older Adults
Major Depressive Disorder · Dysthymia · Depression Not Otherwise Specified · Decreased Processing Speed · Decreased Gait Speed
Bottom Line
View on ClinicalTrials.gov: NCT02744391 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Hamilton Rating Scale for Depression (24 Item) — 10.94 Units on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levodopa (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Rating Scale for Depression (24 Item) |
10.94 | — |
| SECONDARY Digit Symbol Substitution Test |
41.42 | — |
| SECONDARY Digit Symbol Substitution Test |
41.42 | — |
| SECONDARY Pattern Comparison |
27.61 | — |
| SECONDARY Pattern Comparison |
27.61 | — |
| SECONDARY Letter Comparison |
15.69 | — |
| SECONDARY Letter Comparison |
15.69 | — |
| SECONDARY Single Task Gait Speed |
.92 | — |
| SECONDARY Single Task Gait Speed |
.92 | — |
| SECONDARY Dual Task Gait Speed |
0.82 | — |
| SECONDARY Dual Task Gait Speed |
0.82 | — |
| SECONDARY Inventory of Depressive Symptomatology-Self Report |
15.09 | — |
| SECONDARY Inventory of Depressive Symptomatology-Self Report |
15.09 | — |
| SECONDARY Pre-Treatment [11C]-Raclopride Binding Potential: Sensorimotor Striatum |
2.43 | — |
| SECONDARY Post-Treatment [11C]-Raclopride Binding Potential: Sensorimotor Striatum |
2.19 | — |
| SECONDARY Pre-Treatment [11C]-Raclopride Binding Potential: Limbic Striatum |
2.04 | — |
| SECONDARY Post-Treatment [11C]-Raclopride Binding Potential: Limbic Striatum |
2.04 | — |
| SECONDARY Pre-Treatment [11C]-Raclopride Binding Potential: Associative Striatum |
2.17 | — |
| SECONDARY Post-Treatment [11C]-Raclopride Binding Potential: Associative Striatum |
2.05 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02744391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.