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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 is a NA study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02943096
The ClinicalTrials.gov registry entry for NCT02943096 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02943096 reports 0 study locations.
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.
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