Heart Rate Variability in Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT02525978
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Primary Completion: 2017-04-12
• Study Completion: 2017-04-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in heart rate variability (HRV, also called RSA)	Baseline, Post-Imaginal Task Session 2 (6 minutes)	RSA is measured by changes in the R-R interval (time between two of the distinctive, large, upward "R" spikes on an electrocardiogram (EKG)) synchronized with respiration. Change is the difference from between RSA at baseline and after imaginal task one week post-infusion.

Secondary Outcome Measures

Name	Time	Method
Mean values of positive emotional expressions	Post-Imaginal Task Session 2 (6 minutes)	Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative).
Change in heart rate	Baseline, Post-Imaginal Task Session 2 (6 minutes)	Heart rate will be measured with the electrocardiogram (EKG) and recorded in beats per minute. Change is the difference from between heart rate at baseline and after the imaginal task one week post-infusion.
Mean values of negative emotional expressions	Post-Imaginal Task Session 2 (6 minutes)	Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the probability of expression of certain emotional states (e.g. neutral, positive, negative).
Change in skin conductance response (SCR)	Baseline, Post-Imaginal Task Session 2 (6 minutes)	The skin conductance will be measured between two leads attached to the participant's the left and right palms which records electrodermal measures. Change is the difference from between SCR at baseline and after the imaginal task one week post-infusion.
Change in pulse rate	Baseline, Post-Imaginal Task Session 2 (6 minutes)	The peripheral pulse rate will be measured by pulse oximeters placed on one finger on the left and right hands. Change is the difference from between pulse rate at baseline and after the imaginal task one week post-infusion.
Mean activation of muscle action units	Post-Imaginal Task Session 2 (6 minutes)	Automated analysis of video data of facial expressions will be carried out using iMotions software (iMotions Inc, Cambridge, MA). This software can calculate the activation of facial muscle action units associated with smiling.
Change in respiration rate	Baseline, Post-Imaginal Task Session 2 (6 minutes)	The respiration rate will be measured by the respiration monitor belt and recorded as number of breaths per minute. Change is the difference from between respiration rate at baseline and after the imaginal task one week post-infusion.

Trial Locations

Locations (3)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

12 Executive Park Drive; 🇺🇸 Atlanta, Georgia, United States

Emory University at Wesley Woods Hospital; 🇺🇸 Atlanta, Georgia, United States