Medical Center investigates Biological Markers, Targets, and Intervention for Mood Disorders
Photo by Francisco Moreno
Vanderbilt University Medical Center is recruiting patients for the clinical trial of Investigating Biological Markers, Targets, and Intervention for Mood Disorders.
This study will investigate neurophysiological, endocrinological, cognitive, psycho-social-emotional markers of disease, and targets for integrative health treatments in mood disorders.
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.
The researchers plan that January 11, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in July 11, 2023.
Among primary outcome measures are the Electroencephalography (EEG) and Event-Related Potentials (ERPs).
There are a number of conditions that do not allow participation, such as:
- 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.
The study will take place at the Vanderbilt University Medical Center, Nashville, Tennessee, United States.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04632498
