Trial Outcomes & Findings for Flavanol Augmentation for Antidepressant Non-Responsive Late Life Depression (NCT NCT02943096)

Last Updated: 2019-09-06

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Week 8

Results posted on

2019-09-06

Participant Flow

We will recruit subjects via advertisements for patients who feel depressed, through the RecruitMe online platform, as well as clinical referrals from colleagues around CUMC.

Every subject evaluated for this protocol will receive a clinical interview by a psychiatrist or psychologist, be administered the 24-item Hamilton Rating Scale for Depression (HRSD) and Antidepressant Treatment History Form, and have a SCID performed by a trained rater. They will be educated about appropriate treatments available for depression.

Participant milestones

Participant milestones
Measure	Flavanol Blinded treatment with either CocoaVia 500mg or placebo. CocoaVia: 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.	Placebo Blinded treatment with either CocoaVia 500mg or placebo. Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").
Overall Study STARTED	3	3
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Flavanol Blinded treatment with either CocoaVia 500mg or placebo. CocoaVia: 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.	Placebo Blinded treatment with either CocoaVia 500mg or placebo. Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Flavanol Augmentation for Antidepressant Non-Responsive Late Life Depression

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Flavanol n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. CocoaVia: 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.	Placebo n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").
Hamilton Rating Scale of Depression (HRSD)	18.3 score on a scale Standard Deviation 6.43	20.3 score on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline

First, participants had to complete an encoding task were they were shown 128 items, ½ objects(2 seconds) and ½ scene (3 seconds). Right after, they were given instructions on a video on how to do the test phase. They were instructed to identified the following images as "old", "similar", or "new". They were then shown 192 items: 64 old items, 64 lures (similar), and 64 foil (new) for 2.5 seconds (objects)/3 seconds (scene). The images were intermixed during the test. The Lure Discrimination Index was calculated as the difference between the rate of "similar" responses give to lure items minus "similar" responses given to foil. This corrected for response bias. Correct responses are those that were identified correctly by the participant. A negative response means that the number of answered correctly was less that those answered incorrectly.

Outcome measures

Outcome measures
Measure	Flavanol n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. CocoaVia: 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.	Placebo n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").
Mnemonic Similarity Task (MST)	-0.0567 Percent Endorsed Standard Deviation .031	0.28 Percent Endorsed Standard Deviation 0.178

SECONDARY outcome

Timeframe: Week 8

The ModBent assesses pattern separation, a measure of cognitive functioning. The task was created to measure dentate gyrus-dependent cognition. It shows participants patterns for 10 seconds, then presents two patterns afterwards on a different screen. Participants are then asked to determine which of the two patterns is the one they previously studied for 10 seconds. The second component of the task then goes through a series of patterns, one by one - the participant has to then decide whether each pattern was one they previously studied for 10 seconds or not. We analyzed the mean Reaction time for correct rejections.

Outcome measures

Outcome measures
Measure	Flavanol n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. CocoaVia: 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.	Placebo n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").
Modified-Benton Task (ModBent)	5459.22 millisecond Standard Deviation 592.67	5820.29 millisecond Standard Deviation 675.79

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Flavanol n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. CocoaVia: 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.	Placebo n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").
Modified-Benton Task (ModBent)	4081.04 millisecond Standard Deviation 412.17	6000.02 millisecond Standard Deviation 403.67

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Flavanol n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. CocoaVia: 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.	Placebo n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").
Mnemonic Similarity Task (MST)	0.15 Percent Endorsed Standard Deviation 0.32	.61 Percent Endorsed Standard Deviation 0.29

Adverse Events

Flavanol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bret R. Rutherford

New York State Psychiatric Institute

Phone: 646-774-8660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Flavanol n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. CocoaVia: 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.	Placebo n=3 Participants Blinded treatment with either CocoaVia 500mg or placebo. Placebo: The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a "sugar pill").	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	71.8 years STANDARD_DEVIATION 5.72 • n=5 Participants	75.2 years STANDARD_DEVIATION 8.93 • n=7 Participants	73.5 years STANDARD_DEVIATION 6.95 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Hamilton Rating Scale for Depression	20 units on a scale STANDARD_DEVIATION 1.73 • n=5 Participants	17 units on a scale STANDARD_DEVIATION 8.72 • n=7 Participants	18.5 units on a scale STANDARD_DEVIATION 5.86 • n=5 Participants