Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1) (NCT04607226) | Clinical Trial Compass
CompletedNot Applicable
Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1)
United States15 participantsStarted 2020-11-02
Plain-language summary
This study will evaluate the short term effects of respiratory-gated transcutaneous vagus nerve stimulation on the regulation of cardiovagal activity, depressive symptomatology and immune function in subjects with major depression and determine the optimal stimulation frequency for this population.
Who can participate
Age range24 Years – 45 Years
SexFEMALE
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Inclusion Criteria:
* Diagnosis of recurrent Major Depressive Disorder with a current active depressive episode
* Currently not taking psychiatric medications or on a stable therapeutic dose of psychiatric medication for at least 30 days prior to entering the study
Exclusion Criteria:
* History of cardio-, cerebro-, or peripheral vascular disease, diabetes mellitus, morbid obesity (BMI \> 40 kg/m2), kidney or liver failure, history of unexplained fainting spells
* Any psychiatric disorder involving a history of psychosis (e.g. schizophrenia, bipolar disorders, severe personality disorders)
* Any chronic condition affecting movement, speech and/or ability to read or follow written instructions
* Substance use disorder, either mild, moderate, or severe within the past 12 months (excludes nicotine)
* History of suicide attempt within the last year or current active suicidal ideation
* History of a clinically defined neurological disorder including, but not limited to: Any condition likely to be associated with increased intracranial pressure; space occupying brain lesion; History of cerebrovascular accident; Transient ischemic attack within two years; Cerebral aneurysm; Dementia; Parkinson's Disease; Huntington's chorea; or Multiple sclerosis.
* Pregnant or nursing
* Metallic implants or devices contraindicating tVNS
What they're measuring
1
Cardiac autonomic function
Timeframe: 1 hour
2
Change in depressive symptoms assessed by the Beck Depression Inventory