Major Depressive DisorderNCT02525978
Heart Rate Variability in Depression
A study testing Video Task and Imaginal Task in people with Major Depressive Disorder, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Video Task and Imaginal Task
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2015to 12 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital
Atlanta, Georgia, 30322
12 Executive Park Drive
Atlanta, Georgia, 30329
Emory University at Wesley Woods Hospital
Atlanta, Georgia, 30329
About this study
Official title: Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults
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
- Being tested
- Video Task, Imaginal Task
- Keywords
- Heart Rate
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video TaskBehavioural
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 TaskOther
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 group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Healthy controls will complete the video task and imaginal task in one session Receives: 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. Receives: Behavioral: Video Task; Other: Imaginal Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Secondary outcomes (28)
Mean values of positive emotional expressions
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).
Measured: Post-Video Task Session 1 (30 minutes)
Mean values of positive emotional expressions
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).
Measured: Post-Imaginal Task Session 1 (6 minutes)
Mean values of negative emotional expressions
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).
Measured: Post-Video Task Session 1 (30 minutes)
Mean values of negative emotional expressions
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).
Measured: Post-Imaginal Task Session 1 (6 minutes)
Mean values of positive emotional expressions
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).
Measured: Post-Video Task Session 2 (30 minutes)
Mean values of positive emotional expressions
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).
Measured: Post-Imaginal Task Session 2 (6 minutes)
Mean values of negative emotional expressions
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).
Measured: Post-Video Task Session 2 (30 minutes)
Mean values of negative emotional expressions
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).
Measured: Post-Imaginal Task Session 2 (6 minutes)
Mean activation of muscle action units
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.
Measured: Post-Video Task Session 1 (30 minutes)
Mean activation of muscle action units
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.
Measured: Post-Imaginal Task Session 1 (6 minutes)
Mean activation of muscle action units
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.
Measured: Post-Video Task Session 2 (30 minutes)
Mean activation of muscle action units
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.
Measured: Post-Imaginal Task Session 2 (6 minutes)
Change in heart rate
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.
Measured: Baseline, Post-Video Task Session 1 (30 minutes)
Change in heart rate
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.
Measured: Baseline, Post-Imaginal Task Session 1 (6 minutes)
Change in heart rate
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.
Measured: Baseline, Post-Video Task Session 2 (30 minutes)
Change in heart rate
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.
Measured: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Change in skin conductance response (SCR)
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.
Measured: Baseline, Post-Video Task Session 1 (30 minutes)
Change in skin conductance response (SCR)
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.
Measured: Baseline, Post-Imaginal Task Session 1 (6 minutes)
Change in skin conductance response (SCR)
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.
Measured: Baseline, Post-Video Task Session 2 (30 minutes)
Change in skin conductance response (SCR)
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.
Measured: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Change in respiration rate
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.
Measured: Baseline, Post-Video Task Session 1 (30 minutes)
Change in respiration rate
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.
Measured: Baseline, Post-Imaginal Task Session 1 (6 minutes)
Change in respiration rate
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.
Measured: Baseline, Post-Video Task Session 2 (30 minutes)
Change in respiration rate
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.
Measured: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Change in pulse rate
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.
Measured: Baseline, Post-Video Task Session 1 (30 minutes)
Change in pulse rate
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.
Measured: Baseline, Post-Imaginal Task Session 1 (6 minutes)
Change in pulse rate
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.
Measured: Baseline, Post-Video Task Session 2 (30 minutes)
Change in pulse rate
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.
Measured: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Crowell, Emory University
- Investigators
- Andrea Crowell, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525978
- Sponsor's protocol ID
- IRB00082047
- Status last verified
- Sep 2019
- First submitted
- 14 Aug 2015
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults
- ClinicalTrials.gov ID
- NCT02525978
- Acronym / sponsor ID
- IRB00082047
- Conditions
- Major Depressive Disorder
- Keywords
- Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Behavioral: Video Task, Other: Imaginal TaskHealthy controls will complete the video task and imaginal task in one session |
| Depressed + Ketamine | Experimental | Behavioral: Video Task, Other: Imaginal TaskSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ages 18-65 years
- Able to understand and provide informed consent
- Male and female
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video TaskSubjects 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. | Behavioural | Depressed + Ketamine, Healthy Controls |
| Imaginal TaskSubjects 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. | Other | Depressed + Ketamine, Healthy Controls |
Primary outcome
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.
28 secondary outcomes
Mean values of positive emotional expressions
Time frame: Post-Video Task Session 1 (30 minutes)
Mean values of positive emotional expressions
Time frame: Post-Imaginal Task Session 1 (6 minutes)
Mean values of negative emotional expressions
Time frame: Post-Video Task Session 1 (30 minutes)
Mean values of negative emotional expressions
Time frame: Post-Imaginal Task Session 1 (6 minutes)
Mean values of positive emotional expressions
Time frame: Post-Video Task Session 2 (30 minutes)
Mean values of positive emotional expressions
Time frame: Post-Imaginal Task Session 2 (6 minutes)
Mean values of negative emotional expressions
Time frame: Post-Video Task Session 2 (30 minutes)
Mean values of negative emotional expressions
Time frame: Post-Imaginal Task Session 2 (6 minutes)
Mean activation of muscle action units
Time frame: Post-Video Task Session 1 (30 minutes)
Mean activation of muscle action units
Time frame: Post-Imaginal Task Session 1 (6 minutes)
Mean activation of muscle action units
Time frame: Post-Video Task Session 2 (30 minutes)
Mean activation of muscle action units
Time frame: Post-Imaginal Task Session 2 (6 minutes)
Change in heart rate
Time frame: Baseline, Post-Video Task Session 1 (30 minutes)
Change in heart rate
Time frame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
Change in heart rate
Time frame: Baseline, Post-Video Task Session 2 (30 minutes)
Change in heart rate
Time frame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Change in skin conductance response (SCR)
Time frame: Baseline, Post-Video Task Session 1 (30 minutes)
Change in skin conductance response (SCR)
Time frame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
Change in skin conductance response (SCR)
Time frame: Baseline, Post-Video Task Session 2 (30 minutes)
Change in skin conductance response (SCR)
Time frame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Change in respiration rate
Time frame: Baseline, Post-Video Task Session 1 (30 minutes)
Change in respiration rate
Time frame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
Change in respiration rate
Time frame: Baseline, Post-Video Task Session 2 (30 minutes)
Change in respiration rate
Time frame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Change in pulse rate
Time frame: Baseline, Post-Video Task Session 1 (30 minutes)
Change in pulse rate
Time frame: Baseline, Post-Imaginal Task Session 1 (6 minutes)
Change in pulse rate
Time frame: Baseline, Post-Video Task Session 2 (30 minutes)
Change in pulse rate
Time frame: Baseline, Post-Imaginal Task Session 2 (6 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Crowell, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Task and Imaginal Task in people with Major Depressive Disorder, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate variability (HRV, also called RSA) (time frame: Baseline, Post-Video Task Session 1 (30 minutes)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.