Status:
COMPLETED
Vagus Nerve Stimulation: Integration of Behavior and Cardiac Modulation
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
FEMALE
25-40 years
Phase:
NA
Brief Summary
This study characterized the impact of respiratory-gated transcutaneous vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry, vagal tone and depressed mood in patients wit...
Detailed Description
Major depressive disorder (MDD) has been associated with alterations of the stress response circuitry, including the hypothalamus, amygdala, hippocampus, anterior cingulate cortex, ventromedial, dorso...
Eligibility Criteria
Inclusion
- Recurrent MDD diagnosis (≥ 2 episodes) with a current active depressive episode.
Exclusion
- History of Axis I psychiatric diagnosis other than MDD or anxiety disorder - e.g., substance use disorder, psychotic disorder, or bipolar disorder.
- Current Suicidal Ideation with intent and/or plan or history of suicide attempt within the last year
- Use of psychotropic medications within four weeks prior to study with the exception of Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Norepinephrine Reuptake Inhibitors (SNRIs) class of antidepressant medication only
- Use of Tricyclic antidepressants (TCAs), Monoamine oxidase inhibitors (MAOIs), and Atypical agents
- History of cardiovascular disease
- History of neuroleptic use
- Past history of substance abuse or dependence within the past 12 months (excludes nicotine)
- Bleeding disorder or use of anticoagulants.
- Pregnancy
- Metallic implants or devices contraindicating magnetic resonance imaging.
- Use of beta blockers
Key Trial Info
Start Date :
April 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04467164
Start Date
April 15 2015
End Date
September 22 2018
Last Update
March 27 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114