Back to resultsHeart Rate Variability in Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Task
Imaginal Task
Sponsored by
About this trial
This is an interventional other trial for Major Depressive Disorder focused on measuring Heart Rate
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
Sites / Locations
- Emory University Hospital
- 12 Executive Park Drive
- Emory University at Wesley Woods Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Controls
Depressed + Ketamine
Arm Description
Healthy controls will complete the video task and imaginal task in one session
Subjects with major depressive disorder (MDD) who are scheduled to receive ketamine infusions will complete the video task and imaginal task twice. The first visit will be before any ketamine treatment. The second visit will be within 1 week after first ketamine infusion. This is NOT at treatment study. Study inclusion is open to participants with MDD who are already planning to receive ketamine treatment at Emory. No treatment is offered through this study.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02525978
Brief Title
Heart Rate Variability in Depression
Official Title
Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
April 12, 2017 (Actual)
Study Completion Date
April 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Heart Rate
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
Healthy controls will complete the video task and imaginal task in one session
Arm Title
Depressed + Ketamine
Arm Type
Experimental
Arm Description
Subjects with major depressive disorder (MDD) who are scheduled to receive ketamine infusions will complete the video task and imaginal task twice. The first visit will be before any ketamine treatment. The second visit will be within 1 week after first ketamine infusion. This is NOT at treatment study. Study inclusion is open to participants with MDD who are already planning to receive ketamine treatment at Emory. No treatment is offered through this study.
Intervention Type
Behavioral
Intervention Name(s)
Video Task
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Imaginal Task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in heart rate variability (HRV, also called RSA)
Description
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.
Time Frame
Baseline, Post-Video Task Session 1 (30 minutes)
Title
Change in heart rate variability (HRV, also called RSA)
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 1 (6 minutes)
Title
Change in heart rate variability (HRV, also called RSA)
Description
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.
Time Frame
Baseline, Post-Video Task Session 2 (30 minutes)
Title
Change in heart rate variability (HRV, also called RSA)
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 2 (6 minutes)
Secondary Outcome Measure Information:
Title
Mean values of positive emotional expressions
Description
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).
Time Frame
Post-Video Task Session 1 (30 minutes)
Title
Mean values of positive emotional expressions
Description
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).
Time Frame
Post-Imaginal Task Session 1 (6 minutes)
Title
Mean values of negative emotional expressions
Description
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).
Time Frame
Post-Video Task Session 1 (30 minutes)
Title
Mean values of negative emotional expressions
Description
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).
Time Frame
Post-Imaginal Task Session 1 (6 minutes)
Title
Mean values of positive emotional expressions
Description
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).
Time Frame
Post-Video Task Session 2 (30 minutes)
Title
Mean values of positive emotional expressions
Description
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).
Time Frame
Post-Imaginal Task Session 2 (6 minutes)
Title
Mean values of negative emotional expressions
Description
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).
Time Frame
Post-Video Task Session 2 (30 minutes)
Title
Mean values of negative emotional expressions
Description
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).
Time Frame
Post-Imaginal Task Session 2 (6 minutes)
Title
Mean activation of muscle action units
Description
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.
Time Frame
Post-Video Task Session 1 (30 minutes)
Title
Mean activation of muscle action units
Description
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.
Time Frame
Post-Imaginal Task Session 1 (6 minutes)
Title
Mean activation of muscle action units
Description
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.
Time Frame
Post-Video Task Session 2 (30 minutes)
Title
Mean activation of muscle action units
Description
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.
Time Frame
Post-Imaginal Task Session 2 (6 minutes)
Title
Change in heart rate
Description
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.
Time Frame
Baseline, Post-Video Task Session 1 (30 minutes)
Title
Change in heart rate
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 1 (6 minutes)
Title
Change in heart rate
Description
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.
Time Frame
Baseline, Post-Video Task Session 2 (30 minutes)
Title
Change in heart rate
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 2 (6 minutes)
Title
Change in skin conductance response (SCR)
Description
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.
Time Frame
Baseline, Post-Video Task Session 1 (30 minutes)
Title
Change in skin conductance response (SCR)
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 1 (6 minutes)
Title
Change in skin conductance response (SCR)
Description
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.
Time Frame
Baseline, Post-Video Task Session 2 (30 minutes)
Title
Change in skin conductance response (SCR)
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 2 (6 minutes)
Title
Change in respiration rate
Description
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.
Time Frame
Baseline, Post-Video Task Session 1 (30 minutes)
Title
Change in respiration rate
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 1 (6 minutes)
Title
Change in respiration rate
Description
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.
Time Frame
Baseline, Post-Video Task Session 2 (30 minutes)
Title
Change in respiration rate
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 2 (6 minutes)
Title
Change in pulse rate
Description
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.
Time Frame
Baseline, Post-Video Task Session 1 (30 minutes)
Title
Change in pulse rate
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 1 (6 minutes)
Title
Change in pulse rate
Description
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.
Time Frame
Baseline, Post-Video Task Session 2 (30 minutes)
Title
Change in pulse rate
Description
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.
Time Frame
Baseline, Post-Imaginal Task Session 2 (6 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Crowell, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
12 Executive Park Drive
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Emory University at Wesley Woods Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Heart Rate Variability in Depression
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