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Heart Rate Variability in Depression

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ClinicalTrials.gov Identifier: NCT02525978
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Crowell, Emory University

Tracking Information
First Submitted Date  ICMJE August 14, 2015
First Posted Date  ICMJE August 18, 2015
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date April 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Rate Variability in Depression
Official Title  ICMJE Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Healthy Controls
    Healthy controls will complete the video task and imaginal task in one session
    Interventions:
    • Behavioral: Video Task
    • Other: Imaginal Task
  • 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.
    Interventions:
    • Behavioral: Video Task
    • Other: Imaginal Task
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2015)
30
Actual Study Completion Date  ICMJE April 12, 2017
Actual Primary Completion Date April 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02525978
Other Study ID Numbers  ICMJE IRB00082047
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Crowell, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Crowell, MD Emory University
PRS Account Emory University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP