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Completed

NCT Number: NCT02525978

Heart Rate Variability in Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

12 Executive Park Drive, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Task

Behavioral

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.

Imaginal Task

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2015
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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