Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Depression Clinical Trial

Official title:

Investigating Biological Markers, Targets, and Intervention for Mood Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04632498
• Other study ID #: IRB #201645
• Status: Terminated
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: April 3, 2024

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: April 3, 2024
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Mood Disorders
• Stress

Intervention

Behavioral:
• Mindfulness Based Intervention
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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Measures	Depression Symptoms	36 months
Other	Clinical Measures	Anxiety Symptoms	36 months
Other	Five Facet Mindfulness Questionnaire (FFMQ)	A 39-item assessment of trait mindfulness (encompassing observing, describing, acting with awareness, non-judging, and non-reactivity).	36 months
Other	Rumination Response Scale (RRS)	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.	36 months
Primary	Electroencephalography (EEG)	Event-Related Potentials (ERPs)	36 months
Primary	Electroencephalography (EEG)	Oscillatory Activity	36 months
Secondary	Endocrine Measures	Oxytocin, Cortisol	36 months
Secondary	Cognitive Behavioral Measure	Executive Functioning	36 months
Secondary	Cognitive Behavioral Measure	Working Memory	36 months
Secondary	Cognitive Behavioral Measure	Social Emotional Processing	36 months