Flavanol Augmentation for Antidepressant Non-Responsive Late Life Depression

NCT02943096 | Terminated Results

• 1 other identifier: 7368
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale of Depression (HRSD)

  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 outcome.

  Week 8

Secondary Outcomes (4)

• Mnemonic Similarity Task (MST)

  Baseline

• Modified-Benton Task (ModBent)

  Week 8

• Modified-Benton Task (ModBent)

  Baseline

• Mnemonic Similarity Task (MST)

  Week 8

Study Arms (2)

Flavanol

ACTIVE COMPARATOR

Blinded treatment with either CocoaVia 500mg or placebo.

Dietary Supplement: CocoaVia

Placebo

PLACEBO COMPARATOR

Blinded treatment with either CocoaVia 500mg or placebo.

Other: Placebo

Interventions

CocoaVia DIETARY_SUPPLEMENT

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.

Flavanol

Placebo OTHER

The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged ≥60 years (Method of ascertainment: clinical interview)
• DSM 5 diagnosis of Major Depressive Disorder (Method of ascertainment: SCID, clinical interview)
• Subjective report of memory or thinking problems (Method of ascertainment: clinical interview)
• item Hamilton Rating Scale for Depression ≥16 (Method of ascertainment: HRSD)
• Failure of depressive symptoms to remit following an adequate trial of an antidepressant (defined as at least 8 weeks of treatment, with 4 weeks of at least half PDR maximum dose, of an FDA approved antidepressant) (Method of ascertainment: clinical interview)
• Capable of providing informed consent and complying with the study procedures (Method of ascertainment: clinical interview)

You may not qualify if:

• Diagnosis of Substance Use Disorder within the past 12 months (excluding Tobacco) (Method of ascertainment: SCID, clinical interview)
• History of psychosis, psychotic disorder, mania, or bipolar disorder (Method of ascertainment: SCID, clinical interview)
• HRSD suicide item \> 2 or CGI =7 at baseline (Method of ascertainment: HRSD, CGI)
• Diagnosis of probable or definite dementia (Alzheimer's Disease, Vascular Dementia, Parkinson's disease, etc.) (Method of ascertainment: SCID, clinical interview, MMSE)
• MMSE ≤24 (Method of ascertainment: MMSE)
• Physical or intellectual disability adversely affecting ability to complete assessments (Method of ascertainment: clinical interview)
• History of allergy, hypersensitivity, or intolerance to cocoa flavanols (Method of ascertainment: clinical interview)
• Contraindication to MRI scanning or unable to tolerate scanning procedures (Method of ascertainment: clinical interview)
• Allergic or adverse reaction to gadolinium, 2 or more prior scans with gadolinium, or creatinine clearance \< 50 (Method of ascertainment: clinical interview, blood draw)
• Daily consumers of dietary or herbal supplements, including Gingko, flavonoid, and dietary herbal or plant extracts (Method of ascertainment: clinical interview)
• Diabetes or acute, severe, or unstable medical or neurologic condition (Method of ascertainment: clinical interview, physical exam, EKG)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Columbia University: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Bret R. Rutherford
• Organization: New York State Psychiatric Institute

brr8@cumc.columbia.edu

646-774-8660

Study Officials

• Bret Rutherford, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 24, 2016
• Study Start: November 1, 2016
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)