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NCT02943096 · ClinicalTrials.gov registry record · NA
Flavanol Augmentation for Antidepressant Non-Responsive Late Life Depression
A NA study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT02943096: Clinical Trial NA study, sponsored by New York State Psychiatric Institute.
NCT02943096 is a NA study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02943096, a NA study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this proposal is to conduct the first pilot study of whether consuming flavanol supplements will augment the cognitive and mood benefits of antidepressant medication in older adults with Late LifeDepression (LLD). Flavanols represent a specific group of plant derived nutrients that are found in cocoa beans, grapes, tea, berries and various other fruits and vegetables. The specific flavanols investigated in this study come from cocoa. Currently available treatments for LLD (i.e., antidepressant medication) are limited in efficacy, especially in individuals who also suffer from cognitive impairment. Recent studies performed at Columbia and elsewhere suggest that flavanols may induce beneficial brain changes that support cognitive functioning and elevate mood, but their precise clinical effects in older adults with combined depression and cognitive impairment remain to be evaluated. For this study, the investigators plan to recruit 50 adults aged ≥60 years who have Major Depressive Disorder, meet a minimum depressive symptom threshold despite currently receiving an adequate trial of an antidepressant, and have a significant cognitive complaints without a diagnosis of dementia. Subjects will be randomized to receive 8 weeks of augmentation treatment with flavanol capsules (in addition to continuing their antidepressant) vs. capsules not containing flavanols. Pre- and post-treatment MRI scanning of the brain will be conducted, and comprehensive pre- and post-treatment neuropsychological assessment will be performed. Results from this project will allow the investigators 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.
Primary Outcome
Scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 24 items. The minimum score is 0 and the maximum score is 74. The higher the number the worse ou
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT CocoaVia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-02-06 |
| Phase | NA |
Why NCT02943096 stopped before completion
NCT02943096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02943096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02943096 about?
NCT02943096 is a clinical study titled "Flavanol Augmentation for Antidepressant Non-Responsive Late Life Depression". The goal of this proposal is to conduct the first pilot study of whether consuming flavanol supplements will augment the cognitive and mood benefits of antidepressant medication in older adults with Late LifeDepression (LLD). Flavanols represent a specific group of plant derived nutrients that are f...
What is the current status of trial NCT02943096?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2016-11. Estimated completion is 2018-02-06.
What interventions are being tested in trial NCT02943096?
The interventions under investigation include: Placebo (OTHER), CocoaVia (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02943096?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02943096's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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