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Heart Rate Variability in Depression

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ClinicalTrials.gov Identifier: NCT02525978
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea Crowell, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Video Task Other: Imaginal Task Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults
Study Start Date : July 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Controls
Healthy controls will complete the video task and imaginal task in one session
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.

Experimental: Depressed + Ketamine
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.
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.




Primary Outcome Measures :
  1. Change in heart rate variability (HRV, also called RSA) [ Time Frame: Baseline, Post-Video Task Session 1 (30 minutes) ]
    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.

  2. Change in heart rate variability (HRV, also called RSA) [ Time Frame: Baseline, Post-Imaginal Task Session 1 (6 minutes) ]
    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.

  3. Change in heart rate variability (HRV, also called RSA) [ Time Frame: Baseline, Post-Video Task Session 2 (30 minutes) ]
    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.

  4. Change in heart rate variability (HRV, also called RSA) [ Time Frame: 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 :
  1. Mean values of positive emotional expressions [ Time Frame: Post-Video Task Session 1 (30 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).

  2. Mean values of positive emotional expressions [ Time Frame: Post-Imaginal Task Session 1 (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).

  3. Mean values of negative emotional expressions [ Time Frame: Post-Video Task Session 1 (30 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).

  4. Mean values of negative emotional expressions [ Time Frame: Post-Imaginal Task Session 1 (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).

  5. Mean values of positive emotional expressions [ Time Frame: Post-Video Task Session 2 (30 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).

  6. Mean values of positive emotional expressions [ Time Frame: 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).

  7. Mean values of negative emotional expressions [ Time Frame: Post-Video Task Session 2 (30 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).

  8. Mean values of negative emotional expressions [ Time Frame: 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).

  9. Mean activation of muscle action units [ Time Frame: Post-Video Task Session 1 (30 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.

  10. Mean activation of muscle action units [ Time Frame: Post-Imaginal Task Session 1 (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.

  11. Mean activation of muscle action units [ Time Frame: Post-Video Task Session 2 (30 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.

  12. Mean activation of muscle action units [ Time Frame: 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.

  13. Change in heart rate [ Time Frame: Baseline, Post-Video Task Session 1 (30 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 video task.

  14. Change in heart rate [ Time Frame: Baseline, Post-Imaginal Task Session 1 (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.

  15. Change in heart rate [ Time Frame: Baseline, Post-Video Task Session 2 (30 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 video task one week post-infusion.

  16. Change in heart rate [ Time Frame: 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.

  17. Change in skin conductance response (SCR) [ Time Frame: Baseline, Post-Video Task Session 1 (30 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 video task.

  18. Change in skin conductance response (SCR) [ Time Frame: Baseline, Post-Imaginal Task Session 1 (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.

  19. Change in skin conductance response (SCR) [ Time Frame: Baseline, Post-Video Task Session 2 (30 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 video task one week post-infusion.

  20. Change in skin conductance response (SCR) [ Time Frame: 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.

  21. Change in respiration rate [ Time Frame: Baseline, Post-Video Task Session 1 (30 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 video task.

  22. Change in respiration rate [ Time Frame: Baseline, Post-Imaginal Task Session 1 (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.

  23. Change in respiration rate [ Time Frame: Baseline, Post-Video Task Session 2 (30 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 video task one week post-infusion.

  24. Change in respiration rate [ Time Frame: 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.

  25. Change in pulse rate [ Time Frame: Baseline, Post-Video Task Session 1 (30 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 video task.

  26. Change in pulse rate [ Time Frame: Baseline, Post-Imaginal Task Session 1 (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.

  27. Change in pulse rate [ Time Frame: Baseline, Post-Video Task Session 2 (30 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 video task one week post-infusion.

  28. Change in pulse rate [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525978


Contacts
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Contact: Andrea Crowell, MD 404-727-2397 andrea.crowell@emory.edu

Locations
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United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Andrea Crowell, MD    404-727-2397    andrea.crowell@emory.edu   
12 Executive Park Drive Recruiting
Atlanta, Georgia, United States, 30329
Contact: Andrea Crowell, MD    404-727-2397    andrea.crowell@emory.edu   
Emory University at Wesley Woods Hospital Recruiting
Atlanta, Georgia, United States, 30329
Contact: Andrea Crowell, MD    404-727-2397    andrea.crowell@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Andrea Crowell, MD Emory University

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Responsible Party: Andrea Crowell, Senior Associate, Emory University
ClinicalTrials.gov Identifier: NCT02525978     History of Changes
Other Study ID Numbers: IRB00082047
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Andrea Crowell, Emory University:
Heart Rate

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action