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Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Primary Purpose

Major Depressive Disorder, Depression, Stress

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness Based Intervention

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring EEG/ERP, Neurophysiology, Endocrine, Cognitive, Mindfulness, Mechanistic Clinical Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Patients:

Age range: 18-65 years
Must possess English language skills sufficient for providing informed consent, completing questionnaires, and understanding instructions
If currently taking maintenance anti-depressant and/or anti-anxiety medication, must have a "stable" regimen as indexed by no medication or dosage changes within the past month
IDS score ≥18
Currently depressed patients will be defined as: PHQ-9 score range 15 - 27 (moderately severe/severe depressive severity)
Remitted depressed patients will be defined as: number of depressive episodes must be ≥ 3 and a PHQ-9 score of < 5 (minimal depression)

Blood Collection Inclusion:

At least 110 pounds
Generally healthy by self-report on day of collection (i.e., free of cold and flu symptoms on the day of collection, no infections within two weeks prior to collection, no known sickle cell disease)
Including the study draw, blood donation for clinical or research purposes within the preceding eight weeks will not exceed 550 mL
No more than one blood draw will have occurred during the preceding week

Exclusion Criteria for Patients:

Prior diagnosis of bipolar I, bipolar II, psychotic personality disorder, borderline personality disorder, and/or narcissistic personality disorder
Current history (equal/less than 6 months) of substance abuse/dependence
Current history (equal/less than 6 months) of regular meditation practice (>1 session/week; >10 min/session)
History of medical illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g., stroke) or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes)
Current suicidal ideation

Exclusion Criteria for Healthy Controls:

Previous or current mental health history (depression)
Current history (equal/less than 6 months) of substance abuse/dependence
History of medical illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g., stroke) or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes)
Current suicidal ideation

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness Based Intervention (MBI)

Wait-list Control (WL)

Healthy Control (HC)

Arm Description

Patients Active Intervention group

Patient Control receiving no treatment

Healthy Control receiving no treatment

Outcomes

Primary Outcome Measures

Electroencephalography (EEG)

Event-Related Potentials (ERPs)

Electroencephalography (EEG)

Oscillatory Activity

Secondary Outcome Measures

Endocrine Measures

Oxytocin, Cortisol

Cognitive Behavioral Measure

Executive Functioning

Cognitive Behavioral Measure

Working Memory

Cognitive Behavioral Measure

Social Emotional Processing

Full Information

NCT ID

NCT04632498

First Posted

October 29, 2020

Last Updated

September 18, 2023

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04632498

Brief Title

Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Official Title

Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Suspended

Why Stopped

Phase I enrolment and testing completed. Future Phase II enrolment/testing is anticipated.

Study Start Date

October 26, 2021 (Actual)

Primary Completion Date

January 15, 2022 (Actual)

Study Completion Date

January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This multi-modal methods study will investigate neurophysiological, endocrinological, cognitive, psycho-social-emotional markers of disease, and targets for integrative health treatments in mood disorders.

Detailed Description

It is estimated that 16.2 million adults in the USA suffer at least one depressive episode any given year. Mood disorders are associated with decreased quality of life, attention, memory, and executive function deficits, and increased health care cost. Despite successful medication and psychotherapies, mood disorders rarely respond completely to common treatment options. MBI's offer a low-cost, non-pharmacological alternative with accruing efficacy. Developing robust and specific non-pharmacologic intervention programs, on par with pharmacological clinical outcomes without harmful side-effects is a crucial unmet clinical need and a research priority for the NCCIH. Understanding the mechanistic pathways of these interventions is key to their clinical development and implementation for treating depression in primary care. Mindfulness-Based Interventions (MBIs) show similar clinical efficacy for mood disorders as pharmacology, and co-morbid symptoms of depression and anxiety. There is substantial consistent and replicated empirical evidence across multiple clinical sites highlighting the clinical efficacy of MBI in decreasing risk of depressive relapse ascertained from randomized RCTs comparing MBI with treatment as usual. Meta-analysis including 183 patients with Multiple Sclerosis showed efficacy in psychosocial outcomes, quality of life, anxiety, depression, and select physical symptoms including fatigue, pain, and vestibular symptoms. The clinical efficacy of MBIs appears to extend mood disorders, as a systematic review including 13 studies in fibromyalgia, chronic fatigue, and irritable bowel syndrome showed significant effect sizes, reported as standardized mean difference (SMD), compared to control conditions in reducing depression (SMD= -.23), anxiety (SMD= -.20), symptom severity (SMD= -.40), and pain (SMD= -.21). Cognitively, MBIs appear to enhance executive control and self-regulatory processing, that has a beneficial effect upon emotion regulation, pain perception, and has shown to reduce rumination in depression. This overarching study aims to identify key phenotypic markers and treatment targets of mood disorders, and further understand MBI mechanism in its treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Depression, Stress

Keywords

EEG/ERP, Neurophysiology, Endocrine, Cognitive, Mindfulness, Mechanistic Clinical Trial

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness Based Intervention (MBI)

Arm Type

Experimental

Arm Description

Patients Active Intervention group

Arm Title

Wait-list Control (WL)

Arm Type

No Intervention

Arm Description

Patient Control receiving no treatment

Arm Title

Healthy Control (HC)

Arm Type

No Intervention

Arm Description

Healthy Control receiving no treatment

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Based Intervention

Other Intervention Name(s)

MBI

Intervention Description

Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed

Primary Outcome Measure Information:

Title

Electroencephalography (EEG)

Description

Event-Related Potentials (ERPs)

Time Frame

36 months

Title

Electroencephalography (EEG)

Description

Oscillatory Activity

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Endocrine Measures

Description

Oxytocin, Cortisol

Time Frame

36 months

Title

Cognitive Behavioral Measure

Description

Executive Functioning

Time Frame

36 months

Title

Cognitive Behavioral Measure

Description

Working Memory

Time Frame

36 months

Title

Cognitive Behavioral Measure

Description

Social Emotional Processing

Time Frame

36 months

Other Pre-specified Outcome Measures:

Title

Clinical Measures

Description

Depression Symptoms

Time Frame

36 months

Title

Clinical Measures

Description

Anxiety Symptoms

Time Frame

36 months

Title

Five Facet Mindfulness Questionnaire (FFMQ)

Description

A 39-item assessment of trait mindfulness (encompassing observing, describing, acting with awareness, non-judging, and non-reactivity).

Time Frame

36 months

Title

Rumination Response Scale (RRS)

Description

22-item assessment that reliably assesses rumination and not confounded by depression. The 22 items of the RRS measure two aspects of rumination, brooding and reflective pondering.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for Patients: Age range: 18-65 years Must possess English language skills sufficient for providing informed consent, completing questionnaires, and understanding instructions If currently taking maintenance anti-depressant and/or anti-anxiety medication, must have a "stable" regimen as indexed by no medication or dosage changes within the past month IDS score ≥18 Currently depressed patients will be defined as: PHQ-9 score range 15 - 27 (moderately severe/severe depressive severity) Remitted depressed patients will be defined as: number of depressive episodes must be ≥ 3 and a PHQ-9 score of < 5 (minimal depression) Blood Collection Inclusion: At least 110 pounds Generally healthy by self-report on day of collection (i.e., free of cold and flu symptoms on the day of collection, no infections within two weeks prior to collection, no known sickle cell disease) Including the study draw, blood donation for clinical or research purposes within the preceding eight weeks will not exceed 550 mL No more than one blood draw will have occurred during the preceding week Exclusion Criteria for Patients: Prior diagnosis of bipolar I, bipolar II, psychotic personality disorder, borderline personality disorder, and/or narcissistic personality disorder Current history (equal/less than 6 months) of substance abuse/dependence Current history (equal/less than 6 months) of regular meditation practice (>1 session/week; >10 min/session) History of medical illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g., stroke) or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes) Current suicidal ideation Exclusion Criteria for Healthy Controls: Previous or current mental health history (depression) Current history (equal/less than 6 months) of substance abuse/dependence History of medical illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g., stroke) or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes) Current suicidal ideation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Poppy LA Schoenberg, PhD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The PI will adhere to the NIH Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. Quality-controlled raw data as well as processed data used in publications will be de-identified before sharing upon "reasonable request". As described in the proposal, workflows and structure will be exactly described in reports and documented to allow precisely reproduce results from raw data and replicate methodology. Final data (computerized datasets with raw data and derived variables) that have not yet been published will be shared in a timely manner. Software programs (i.e. experimental paradigm scripts produced for this study) and documentation will be made available for research purposes to replicate findings upon "reasonable request", and any software/script sharing requirements by journals.

IPD Sharing Time Frame

36 months

Learn more about this trial

Investigating Biological Markers, Targets, and Intervention for Mood Disorders

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