Clinical trial NCT02525978: Heart Rate Variability in Depression
Official title: Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Heart Rate
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to understand if there is a relationship between the way that emotions are regulated by the brain and the way that heart rate is regulated by the brain. The study also seeks to understand whether having depression changes the way that emotions and heart rate are regulated.


Eligibility criteria: Inclusion Criteria:

* Ages 18-65 years
* Able to understand and provide informed consent
* Male and female

Depressed Subjects:

* Current diagnosis of major depressive disorder (MDD) and currently in an major depressive episode (MDE)
* Quick Inventory of Depressive Symptomology (QIDS-SR16) score of 11 or greater
* Anticipated treatment with ketamine infusion for depression

Exclusion Criteria:

* Current daily use of tricyclic antidepressants
* Current diagnosis of cardiac arrhythmia or heart failure
* Pregnancy
* Current use of cardiac medications of the class beta-blockers
* Current treatment with deep brain stimulation for any reason

Healthy Controls:

* Current psychiatric treatment, including use of antidepressants or daily use of anxiolytic medication

Depressed Subjects:

* Previous history of ketamine infusion for depression
* Psychotic symptoms
* Active co-morbid psychiatric diagnosis including anxiety disorder or personality disorder that significantly affects the current clinical condition, as determined by medical records

Primary outcomes:
measure: Change in heart rate variability (HRV, also called RSA)
timeFrame: Baseline, Post-Video Task Session 1 (30 minutes)
measure: Change in heart rate variability (HRV, also called RSA)
timeFrame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
measure: Change in heart rate variability (HRV, also called RSA)
timeFrame: Baseline, Post-Video Task Session 2 (30 minutes)
measure: Change in heart rate variability (HRV, also called RSA)
timeFrame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Secondary outcomes:
measure: Mean values of positive emotional expressions
timeFrame: Post-Video Task Session 1 (30 minutes)
measure: Mean values of positive emotional expressions
timeFrame: Post-Imaginal Task Session 1 (6 minutes)
measure: Mean values of negative emotional expressions
timeFrame: Post-Video Task Session 1 (30 minutes)
measure: Mean values of negative emotional expressions
timeFrame: Post-Imaginal Task Session 1 (6 minutes)
measure: Mean values of positive emotional expressions
timeFrame: Post-Video Task Session 2 (30 minutes)
measure: Mean values of positive emotional expressions
timeFrame: Post-Imaginal Task Session 2 (6 minutes)
measure: Mean values of negative emotional expressions
timeFrame: Post-Video Task Session 2 (30 minutes)
measure: Mean values of negative emotional expressions
timeFrame: Post-Imaginal Task Session 2 (6 minutes)
measure: Mean activation of muscle action units
timeFrame: Post-Video Task Session 1 (30 minutes)
measure: Mean activation of muscle action units
timeFrame: Post-Imaginal Task Session 1 (6 minutes)
measure: Mean activation of muscle action units
timeFrame: Post-Video Task Session 2 (30 minutes)
measure: Mean activation of muscle action units
timeFrame: Post-Imaginal Task Session 2 (6 minutes)
measure: Change in heart rate
timeFrame: Baseline, Post-Video Task Session 1 (30 minutes)
measure: Change in heart rate
timeFrame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
measure: Change in heart rate
timeFrame: Baseline, Post-Video Task Session 2 (30 minutes)
measure: Change in heart rate
timeFrame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
measure: Change in skin conductance response (SCR)
timeFrame: Baseline, Post-Video Task Session 1 (30 minutes)
measure: Change in skin conductance response (SCR)
timeFrame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
measure: Change in skin conductance response (SCR)
timeFrame: Baseline, Post-Video Task Session 2 (30 minutes)
measure: Change in skin conductance response (SCR)
timeFrame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
measure: Change in respiration rate
timeFrame: Baseline, Post-Video Task Session 1 (30 minutes)
measure: Change in respiration rate
timeFrame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
measure: Change in respiration rate
timeFrame: Baseline, Post-Video Task Session 2 (30 minutes)
measure: Change in respiration rate
timeFrame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
measure: Change in pulse rate
timeFrame: Baseline, Post-Video Task Session 1 (30 minutes)
measure: Change in pulse rate
timeFrame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
measure: Change in pulse rate
timeFrame: Baseline, Post-Video Task Session 2 (30 minutes)
measure: Change in pulse rate
timeFrame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: 12 Executive Park Drive
state: Georgia
city: Atlanta
country: United States
facility: Emory University at Wesley Woods Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Andrea Crowell, MD
role: PRINCIPAL_INVESTIGATOR
References: