Heart Rate Variability in Depression

Major Depressive Disorder Clinical Trial

Official title:

Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525978
• Other study ID #: IRB00082047
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: April 12, 2017

Study information

• Verified date: September 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 12, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Video Task
Subjects are asked to watch a series of six two-minute video clips. The video clips are designed to induce sad or happy emotions or no emotion (neutral) and are taken from movies, documentaries, or instructional videos. There are two videos for each emotion condition. Videos and fixation cross screens are viewed on a laptop computer. In between video clips, patients are asked to quietly look at a fixation cross for one minute, describe their emotional reaction to the video for up to one minute, then again attend to a fixation cross for one minute. A video recording of the frontal view of the participant's face will be made during task performance.

Other:
• Imaginal Task
Subjects are asked to think about happy or sad memories for 2 minutes. Subjects are asked to imagine performing neutral tasks, such as buying groceries. Subjects are then asked to think about a memory that makes them feel angry. A video recording of the frontal view of the participant's face will be made during task performance.

Locations

Country	Name	City	State
United States	12 Executive Park Drive	Atlanta	Georgia
United States	Emory University at Wesley Woods Hospital	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate variability (HRV, also called RSA)	HRV is measured as the variations of the time interval between two consecutive cardiac beats registered by means of electrocardiogram (EKG). Change is the difference from between HRV at baseline and after video task.	Baseline, Post-Video Task Session 1 (30 minutes)
Primary	Change in heart rate variability (HRV, also called RSA)	HRV is measured as the variations of the time interval between two consecutive cardiac beats registered by means of electrocardiogram (EKG). Change is the difference from between HRV at baseline and after the imaginal task.	Baseline, Post-Imaginal Task Session 1 (6 minutes)
Primary	Change in heart rate variability (HRV, also called RSA)	HRV is measured as the variations of the time interval between two consecutive cardiac beats registered by means of electrocardiogram (EKG). Change is the difference from between HRV at baseline and after video task one week post-infusion.	Baseline, Post-Video Task Session 2 (30 minutes)
Primary	Change in heart rate variability (HRV, also called RSA)	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.	Baseline, Post-Imaginal Task Session 2 (6 minutes)
Secondary	Mean values of positive emotional expressions	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).	Post-Video Task Session 1 (30 minutes)
Secondary	Mean values of positive emotional expressions	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).	Post-Imaginal Task Session 1 (6 minutes)
Secondary	Mean values of negative emotional expressions	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).	Post-Video Task Session 1 (30 minutes)
Secondary	Mean values of negative emotional expressions	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).	Post-Imaginal Task Session 1 (6 minutes)
Secondary	Mean values of positive emotional expressions	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).	Post-Video Task Session 2 (30 minutes)
Secondary	Mean values of positive emotional expressions	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).	Post-Imaginal Task Session 2 (6 minutes)
Secondary	Mean values of negative emotional expressions	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).	Post-Video Task Session 2 (30 minutes)
Secondary	Mean values of negative emotional expressions	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).	Post-Imaginal Task Session 2 (6 minutes)
Secondary	Mean activation of muscle action units	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.	Post-Video Task Session 1 (30 minutes)
Secondary	Mean activation of muscle action units	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.	Post-Imaginal Task Session 1 (6 minutes)
Secondary	Mean activation of muscle action units	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.	Post-Video Task Session 2 (30 minutes)
Secondary	Mean activation of muscle action units	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.	Post-Imaginal Task Session 2 (6 minutes)
Secondary	Change in heart rate	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 video task.	Baseline, Post-Video Task Session 1 (30 minutes)
Secondary	Change in heart rate	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.	Baseline, Post-Imaginal Task Session 1 (6 minutes)
Secondary	Change in heart rate	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 video task one week post-infusion.	Baseline, Post-Video Task Session 2 (30 minutes)
Secondary	Change in heart rate	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.	Baseline, Post-Imaginal Task Session 2 (6 minutes)
Secondary	Change in skin conductance response (SCR)	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 video task.	Baseline, Post-Video Task Session 1 (30 minutes)
Secondary	Change in skin conductance response (SCR)	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.	Baseline, Post-Imaginal Task Session 1 (6 minutes)
Secondary	Change in skin conductance response (SCR)	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 video task one week post-infusion.	Baseline, Post-Video Task Session 2 (30 minutes)
Secondary	Change in skin conductance response (SCR)	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.	Baseline, Post-Imaginal Task Session 2 (6 minutes)
Secondary	Change in respiration rate	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 video task.	Baseline, Post-Video Task Session 1 (30 minutes)
Secondary	Change in respiration rate	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.	Baseline, Post-Imaginal Task Session 1 (6 minutes)
Secondary	Change in respiration rate	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 video task one week post-infusion.	Baseline, Post-Video Task Session 2 (30 minutes)
Secondary	Change in respiration rate	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.	Baseline, Post-Imaginal Task Session 2 (6 minutes)
Secondary	Change in pulse rate	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 video task.	Baseline, Post-Video Task Session 1 (30 minutes)
Secondary	Change in pulse rate	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.	Baseline, Post-Imaginal Task Session 1 (6 minutes)
Secondary	Change in pulse rate	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 video task one week post-infusion.	Baseline, Post-Video Task Session 2 (30 minutes)
Secondary	Change in pulse rate	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.	Baseline, Post-Imaginal Task Session 2 (6 minutes)