Heart Rate Variability in Depression

NCT02525978 | Completed

• 1 other identifier: IRB00082047
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

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.

Conditions

Major Depressive Disorder

Keywords

Heart Rate

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (28)

• Mean values of positive emotional expressions

  Post-Video Task Session 1 (30 minutes)

• Mean values of positive emotional expressions

  Post-Imaginal Task Session 1 (6 minutes)

• Mean values of negative emotional expressions

  Post-Video Task Session 1 (30 minutes)

• Mean values of negative emotional expressions

  Post-Imaginal Task Session 1 (6 minutes)

• Mean values of positive emotional expressions

  Post-Video Task Session 2 (30 minutes)

Study Arms (2)

Healthy Controls

EXPERIMENTAL

Healthy controls will complete the video task and imaginal task in one session

Behavioral: Video Task; Other: Imaginal Task

Depressed + Ketamine

EXPERIMENTAL

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; Other: Imaginal Task

Interventions

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.

Depressed + Ketamine; Healthy Controls

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.

Depressed + Ketamine; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

12 Executive Park Drive

Atlanta, Georgia, 30329, United States

Location

Emory University at Wesley Woods Hospital

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Andrea Crowell, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 18, 2015
• Study Start: July 1, 2015
• Primary Completion: April 12, 2017
• Study Completion: April 12, 2017
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

US (3)