CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 47 enrolled
Drug / intervention
Levodopadrug
Likely dose
Not stated in record
Key inclusion· 5
  • Age greater than 59 years
  • Non-psychotic Major Depressive Disorder, Dysthymia, or Depression Not Otherwise Specified diagnosed per DSM 5
  • Elevated depressive symptoms on CES-D scale (>9)
  • Decreased processing speed (≥0.5 SD below age norms on Digit Symbol Test) AND decreased gait speed (<1 m/s over 15-foot course)
Key exclusion· 8
  • Diagnosis of substance abuse or dependence (except tobacco) in past 12 months
  • History of or current psychosis, psychotic disorder, mania, or bipolar disorder
  • Probable Alzheimer's Disease, Vascular Dementia, or Parkinson's Disease
  • Severe depression (HRSD ≥25) or significant suicide risk

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02744391
NCT02744391Phase 4Completed

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

New York State Psychiatric Institute·interventional·Posted Apr 20, 2016·Updated Jun 13, 2023

In Brief

A Phase 4 clinical trial evaluating Levodopa for Major Depressive Disorder and 4 related conditions. Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 20, 2016
Enrollment StartAug 24, 2016
Primary CompletionSep 14, 2018
Study CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.2 years ago

Interventions

Levodopadrug