Heart Rate Variability in Depression

NCT ID: NCT02525978

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-04-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy Controls

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

Group Type: EXPERIMENTAL

Video Task

Intervention Type: 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

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Video Task

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Andrea Crowell

Senior Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Crowell, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

12 Executive Park Drive

Atlanta, Georgia, United States

Emory University at Wesley Woods Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00082047

Identifier Type: -

Identifier Source: org_study_id