Depressive Disorder, MajorK-BRAINEDNCT06012916
Brain Network Dynamics of Depression During Esketamine Treatment
An observational study of Depressive Disorder, Major, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a monocentric, observational clinical trial investigating the effect of Esketamine on brain network activity and a belief updating task in people with depression. We investigate the immediate and the long-term effect (approx. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Esketamine nasal spray
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2023to 30 Aug 2024
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The goal is to recruit individuals with an MDD diagnosis who are receiving Esketamine treatment.
Who may be able to join
- Major Depressive Disorder
- Receiving Esketamine nasal spray treatment for depression
- Ability to understand study procedures and sign an informed consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, 27516
About this study
This is a monocentric, observational clinical trial investigating the effect of Esketamine on brain network activity and a belief updating task in people with depression. We investigate the immediate and the long-term effect (approx. 8 weeks) of Esketamine on EEG signals, pupillometry and belief updating and the relation of those effects on depressive symptomatology.
Read the detailed description
The FDA approved the S-enantiomer of Ketamine in a nasal spray formulation (Esketamine, Spravato) in 2019 for treatment resistant depression in conjunction with an oral antidepressant. Albeit showing impressive short term clinical effects, the neurophysiological mechanism leading to clinical improvements are not understood. The investigators aim to add missing knowledge about the network dynamics of Esketamine in depression. Besides changes of neural signatures, Esketamine might impact cognitive processes like belief updating.
Previous studies have shown that people update their expectations of future life events after receiving novel information. The Belief Updating Task (BUT) measures this belief update in reaction to new information. Healthy individuals have been shown to update their beliefs "optimistically", making larger changes in their expectations in response to good news. Individuals with depression lack this optimistic belief update bias. Therefore, the investigators also aim to examine if Esketamine treatment reinstates the optimistic bias, how those changes are mediated by neurophysiological changes during the task and if a change in belief updated is related to a change of depressive symptoms.
The first session takes place at the start of the Esketamine treatment period, whereas the second experimental session is conducted closer to the end of the treatment period. In both experimental sessions, EEG/pupillometry and cognitive measurements are taken before and after Esketamine administration. Analyses will assess pre/post Esketamine effects within a session and between two sessions.
- Conditions
- Depressive Disorder, Major
- Being tested
- Esketamine nasal spray
- Keywords
- Esketamine, Ketamine, Belief Updating, Pupillometry, EEG
- 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.
Esketamine nasal sprayDrug
Also called Spravato
This is an observational study. The Esketamine nasal spray is administered by the attending physician during a regular treatment appointment at the Interventional Psychiatry Clinic. Esketamine dosages may range between 28-84mg. The study does not interfere with the individual treatment plan in any way.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Resistant Depression + Esketamine Treatment | This is a group of individuals with treatment resistant depression receiving Esketamine treatment as prescribed by their physician during outpatient appointments over several weeks at the Interventional Psychiatry outpatient clinic at University of North Carolina at Chapel Hill (UNC). After signing the informed consent, electroencephalogram (EEG) will be recorded before and after Esketamine administration by the attending physician. The participant will perform a cognitive task before and after the Esketamine administration as well as complete self-scored questionnaire regarding depressive symptoms, treatment expectation and Esketamine side-effects. Clinical information like the duration of episode, medication or clinician-rated depression scores will be retrieved from the charting system. Receives: Drug: Esketamine nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Belief Updating in Session 1
Participants rate the likelihood of a negative life event happening to them (E1) and their confidence in the estimate (C1). They are given a base rate (BR), described as the average lifetime probability of that event happening to someone with the same demographics. Participants will then again rate how likely the event could happen to them personally (E2).
Outcome variables: update = |E2 - E1| and estimation error (ER) = |E1 - BR| News: "good news" (BR< E1) or "bad news" (BR>E1) trials.
Within session relationships between update, C1, ER and covariates will be investigated using linear mixed models (LMMs) using an iterative model comparison process. The basic model will include fixed effect of News and a random intercept for individuals (id or ID).
Potential covariates likely include ER, C1, the Revised Life Orientation Test (LOT-R), Ketamine Side Effect Tool (KSET), and scores of depression severity.
Measured: 10 minutes before Esketamine application compared to 2 hours after Esketamine application
Change in Belief Updating in Session 2
Participants rate the likelihood of a negative life event happening to them (E1) and their confidence in the estimate (C1). They are given a base rate (BR), described as the average lifetime probability of that event happening to someone with the same demographics. Participants will then again rate how likely the event could happen to them personally (E2).
Outcome variables: update = |E2 - E1| and estimation error (ER) = |E1 - BR| News: "good news" (BR< E1) or "bad news" (BR>E1) trials.
Within session relationships between update, C1, ER and covariates will be investigated using linear mixed models (LMMs) using an iterative model comparison process. The basic model will include fixed effect of News and a random intercept for ID (individuals).
Potential covariates likely include ER, C1, the Revised Life Orientation Test (LOT-R), Ketamine Side Effect Tool (KSET), and scores of depression severity.
Measured: 10 minutes before Esketamine application compared to 2 hours after Esketamine application
Change in Confidence in Beliefs Questionnaire in Session 1
- Confidence in Beliefs Questionnaire investigates the strengths of belief in statements about the participant and about someone close to them.
- Participants rate how certain they are about each belief, higher values imply higher certainty
- Beliefs about oneself: 12 items (6 positive, 6 negative), Likert Scale 0 to 100, participants make a mark on a line
- Beliefs about others: 12 items (6 positive, 6 negative), Likert Scale 0 to 100, participants make a mark on a line
Measured: 30 minutes before Esketamine application compared to 2 hours after Esketamine application
Change in Confidence in Beliefs Questionnaire in Session 2
- Confidence in Beliefs Questionnaire investigates the strengths of belief in statements about the participant and about someone close to them.
- Participants rate how certain they are about each belief, higher values imply higher certainty
- Beliefs about oneself: 12 items (6 positive, 6 negative), Likert Scale 0 to 100, participants make a mark on a line
- Beliefs about others: 12 items (6 positive, 6 negative), Likert Scale 0 to 100, participants make a mark on a line
Measured: 30 minutes before Esketamine application compared to 2 hours after Esketamine application
Change of Ketamine Side Effect Tool (KSET) in Session 1
- Semi-structured interview to assess side effects of ketamine
- Each item is scores from 0 (=never) to 3 (= severe) points
- Sum scores and individual item scores can be analyzed.
Measured: 5 minutes before Esketamine application, and 50, 95, and 130 minutes after Esketamine application
Change of Ketamine Side Effect Tool (KSET) in Session 2
- Semi-structured interview to assess side effects of ketamine
- Each item is scores from 0 (=never) to 3 (= severe) points
- Sum scores and individual item scores can be analyzed.
Measured: 5 minutes before Esketamine application, and 50, 95, and 130 minutes after Esketamine application
Change in Mood Likert Scale in Session 1
- Likert Scales range from 0 to 100
- Participants make a mark on a line (left end = 0, right end = 100)
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Change in Mood Likert Scale in Session 2
- Likert Scales range from 0 to 100
- Participants make a mark on a line (left end = 0, right end = 100)
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short version (Q-LES-Q-SF)
- Change in Q-LES-Q-SF between Session 1 and Session 2
- Q-LES-Q-SF is a brief, self-scoring quality of life rating scale.
- Maximum percentage is 100%. Higher values imply higher quality of life
Measured: Session 1 and session 2
Change in Patient Health Questionnaire (PHQ-9)
- Change in PHQ-9 between Session 1 and Session 2
- PHQ-9 is a brief, self-scoring depression rating scale. Higher values imply a higher depression severity.
- Cut-off for depression is considered >4 PHQ-9 points
Measured: Session 1 and session 2
Change in Hamilton Depression Rating Scale (HDRS)
- Change in HDRS-17 between Session 1 and Session 2
- HDRS-17 is the most established depression rating scale. Higher values imply a higher depression severity.
- Cut-off for depression is considered >8 HDRS-17 points
Measured: Session 1 and session 2
Change of Resting State EEG - Power in Session 1
- Changes in oscillatory power within an experimental session pre/post Esketamine application
- Power will be analyzed in canonical frequency bands (e.g. alpha, beta, gamma, delta, theta)
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and130 minutes after Esketamine application
Change of Resting State EEG - Power in Session 2
- Changes in oscillatory power within an experimental session pre/post Esketamine application
- Power will be analyzed in canonical frequency bands (e.g. alpha, beta, gamma, delta, theta)
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and130 minutes after Esketamine application
Change of Resting State EEG - Connectivity in Session 1
- Changes in functional connectivity in canonical frequency band within an experimental session pre/post Esketamine application
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Change of Resting State EEG - Connectivity in Session 2
- Changes in functional connectivity in canonical frequency band within an experimental session pre/post Esketamine application
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Change of Resting State EEG - Source in Session 1
- Changes in spatial distribution and source of electric activity in canonical frequency band within an experimental session pre/post Esketamine application
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Change of Resting State EEG - Source in Session 2
- Changes in spatial distribution and source of electric activity in canonical frequency band within an experimental session pre/post Esketamine application
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Change of Resting State EEG - Aperiodic Signal in Session 1
- Changes in slope and offset of the aperiodic EEG signal within an experimental session pre/post Esketamine application
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Change of Resting State EEG - Aperiodic Signal in Session 2
- Changes in slope and offset of the aperiodic EEG signal within an experimental session pre/post Esketamine application
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Change of Resting State EEG - Entropy in Session 1
- Changes of entropy measured in Lempel-Ziv Complexity and mutual information within an experimental session pre/post Esketamine application
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes in after Esketamine application
Change of Resting State EEG - Entropy in Session 2
- Changes of entropy measured in Lempel-Ziv Complexity and mutual information within an experimental session pre/post Esketamine application
Measured: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
Secondary outcomes (6)
Change in Task EEG - Event Related Potential (ERP) in Session 1
- ERP after presentation of baseline will be calculated for trials with good/bad news, low/high estimation error and low/high confidence (-500 to 2000ms)
- We will analyze the amplitude and spatial distribution of canonical ERP such as N1,N2, P3 and late positive potential
Measured: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Task EEG - Event Related Potential (ERP) in Session 2
- ERP after presentation of baseline will be calculated for trials with good/bad news, low/high estimation error and low/high confidence (-500 to 2000ms)
- We will analyze the amplitude and spatial distribution of canonical ERP such as N1,N2, P3 and late positive potential
Measured: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Task EEG - Time Frequency Analysis in Session 1
- Using wavelet convolution we will conduct a time-frequency analysis for good/bad news, low/high estimation error and low/high confidence
- Time of interest -500 to 2000ms after base rate presentation
- Frequency of interest will be 2-40Hz
Measured: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Task EEG - Time Frequency Analysis in Session 2
- Using wavelet convolution we will conduct a time-frequency analysis for good/bad news, low/high estimation error and low/high confidence
- Time of interest -500 to 2000ms after base rate presentation
- Frequency of interest will be 2-40 Hertz (Hz)
Measured: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Pupillometry in Session 1
- Pupil size during good/bad news and high/low estimation error and low/high confidence trials in the belief updating task
- Time-locked around the presentation of the base rate (-500 to 2000ms)
Measured: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Pupillometry in Session 2
- Pupil size during good/bad news and high/low estimation error and low/high confidence trials in the belief updating task
- Time-locked around the presentation of the base rate (-500 to 2000ms)
Measured: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start3 Jul 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012916
- Sponsor's protocol ID
- 22-0696
- Acronym
- K-BRAINED
- Status last verified
- Sep 2024
- First submitted
- 14 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Dynamics of Depression During Esketamine Treatment
- ClinicalTrials.gov ID
- NCT06012916
- Acronym / sponsor ID
- K-BRAINED / 22-0696
- Conditions
- Depressive Disorder, Major
- Keywords
- Esketamine, Ketamine, Belief Updating, Pupillometry, EEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 28 Aug 2023 (actual)
- 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.
This is a monocentric, observational clinical trial investigating the effect of Esketamine on brain network activity and a belief updating task in people with depression. We investigate the immediate and the long-term effect (approx. 8 weeks) of Esketamine on EEG signals, pupillometry and belief updating and the relation of those effects on depressive symptomatology.
Detailed description
The FDA approved the S-enantiomer of Ketamine in a nasal spray formulation (Esketamine, Spravato) in 2019 for treatment resistant depression in conjunction with an oral antidepressant. Albeit showing impressive short term clinical effects, the neurophysiological mechanism leading to clinical improvements are not understood. The investigators aim to add missing knowledge about the network dynamics of Esketamine in depression. Besides changes of neural signatures, Esketamine might impact cognitive processes like belief updating.
Previous studies have shown that people update their expectations of future life events after receiving novel information. The Belief Updating Task (BUT) measures this belief update in reaction to new information. Healthy individuals have been shown to update their beliefs "optimistically", making larger changes in their expectations in response to good news. Individuals with depression lack this optimistic belief update bias. Therefore, the investigators also aim to examine if Esketamine treatment reinstates the optimistic bias, how those changes are mediated by neurophysiological changes during the task and if a change in belief updated is related to a change of depressive symptoms.
The first session takes place at the start of the Esketamine treatment period, whereas the second experimental session is conducted closer to the end of the treatment period. In both experimental sessions, EEG/pupillometry and cognitive measurements are taken before and after Esketamine administration. Analyses will assess pre/post Esketamine effects within a session and between two sessions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Resistant Depression + Esketamine Treatment | – | Drug: Esketamine nasal sprayThis is a group of individuals with treatment resistant depression receiving Esketamine treatment as prescribed by their physician during outpatient appointments over several weeks at the Interventional Psychiatry outpatient clinic at University of North Carolina at Chapel Hill (UNC). After signing the informed consent, electroencephalogram (EEG) will be recorded before and after Esketamine administration by the attending physician. The participant will perform a cognitive task before and after the Esketamine administration as well as complete self-scored questionnaire regarding depressive symptoms, treatment expectation and Esketamine side-effects. Clinical information like the duration of episode, medication or clinician-rated depression scores will be retrieved from the charting system. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The goal is to recruit individuals with an MDD diagnosis who are receiving Esketamine treatment.
Key inclusion criteria (3 listed)
- Major Depressive Disorder
- Receiving Esketamine nasal spray treatment for depression
- Ability to understand study procedures and sign an informed consent.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Esketamine nasal sprayAlso: SpravatoThis is an observational study. The Esketamine nasal spray is administered by the attending physician during a regular treatment appointment at the Interventional Psychiatry Clinic. Esketamine dosages may range between 28-84mg. The study does not interfere with the individual treatment plan in any way. | Drug | Treatment Resistant Depression + Esketamine Treatment |
Primary outcome
Change in Belief Updating in Session 1
Time frame: 10 minutes before Esketamine application compared to 2 hours after Esketamine application
Participants rate the likelihood of a negative life event happening to them (E1) and their confidence in the estimate (C1). They are given a base rate (BR), described as the average lifetime probability of that event happening to someone with the same demographics. Participants will then again rate how likely the event could happen to them personally (E2). Outcome variables: update = |E2 - E1| and estimation error (ER) = |E1 - BR| News: "good news" (BR< E1) or "bad news" (BR>E1) trials. Within session relationships between update, C1, ER and covariates will be investigated using linear mixed models (LMMs) using an iterative model comparison process. The basic model will include fixed effect of News and a random intercept for individuals (id or ID). Potential covariates likely include ER, C1, the Revised Life Orientation Test (LOT-R), Ketamine Side Effect Tool (KSET), and scores of depression severity.
Change in Belief Updating in Session 2
Time frame: 10 minutes before Esketamine application compared to 2 hours after Esketamine application
Participants rate the likelihood of a negative life event happening to them (E1) and their confidence in the estimate (C1). They are given a base rate (BR), described as the average lifetime probability of that event happening to someone with the same demographics. Participants will then again rate how likely the event could happen to them personally (E2). Outcome variables: update = |E2 - E1| and estimation error (ER) = |E1 - BR| News: "good news" (BR< E1) or "bad news" (BR>E1) trials. Within session relationships between update, C1, ER and covariates will be investigated using linear mixed models (LMMs) using an iterative model comparison process. The basic model will include fixed effect of News and a random intercept for ID (individuals). Potential covariates likely include ER, C1, the Revised Life Orientation Test (LOT-R), Ketamine Side Effect Tool (KSET), and scores of depression severity.
Change in Confidence in Beliefs Questionnaire in Session 1
Time frame: 30 minutes before Esketamine application compared to 2 hours after Esketamine application
* Confidence in Beliefs Questionnaire investigates the strengths of belief in statements about the participant and about someone close to them. * Participants rate how certain they are about each belief, higher values imply higher certainty * Beliefs about oneself: 12 items (6 positive, 6 negative), Likert Scale 0 to 100, participants make a mark on a line * Beliefs about others: 12 items (6 positive, 6 negative), Likert Scale 0 to 100, participants make a mark on a line
Change in Confidence in Beliefs Questionnaire in Session 2
Time frame: 30 minutes before Esketamine application compared to 2 hours after Esketamine application
* Confidence in Beliefs Questionnaire investigates the strengths of belief in statements about the participant and about someone close to them. * Participants rate how certain they are about each belief, higher values imply higher certainty * Beliefs about oneself: 12 items (6 positive, 6 negative), Likert Scale 0 to 100, participants make a mark on a line * Beliefs about others: 12 items (6 positive, 6 negative), Likert Scale 0 to 100, participants make a mark on a line
Change of Ketamine Side Effect Tool (KSET) in Session 1
Time frame: 5 minutes before Esketamine application, and 50, 95, and 130 minutes after Esketamine application
* Semi-structured interview to assess side effects of ketamine * Each item is scores from 0 (=never) to 3 (= severe) points * Sum scores and individual item scores can be analyzed.
Change of Ketamine Side Effect Tool (KSET) in Session 2
Time frame: 5 minutes before Esketamine application, and 50, 95, and 130 minutes after Esketamine application
* Semi-structured interview to assess side effects of ketamine * Each item is scores from 0 (=never) to 3 (= severe) points * Sum scores and individual item scores can be analyzed.
Change in Mood Likert Scale in Session 1
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
* Likert Scales range from 0 to 100 * Participants make a mark on a line (left end = 0, right end = 100)
Change in Mood Likert Scale in Session 2
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
* Likert Scales range from 0 to 100 * Participants make a mark on a line (left end = 0, right end = 100)
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short version (Q-LES-Q-SF)
Time frame: Session 1 and session 2
* Change in Q-LES-Q-SF between Session 1 and Session 2 * Q-LES-Q-SF is a brief, self-scoring quality of life rating scale. * Maximum percentage is 100%. Higher values imply higher quality of life
Change in Patient Health Questionnaire (PHQ-9)
Time frame: Session 1 and session 2
* Change in PHQ-9 between Session 1 and Session 2 * PHQ-9 is a brief, self-scoring depression rating scale. Higher values imply a higher depression severity. * Cut-off for depression is considered >4 PHQ-9 points
Change in Hamilton Depression Rating Scale (HDRS)
Time frame: Session 1 and session 2
* Change in HDRS-17 between Session 1 and Session 2 * HDRS-17 is the most established depression rating scale. Higher values imply a higher depression severity. * Cut-off for depression is considered >8 HDRS-17 points
Change of Resting State EEG - Power in Session 1
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and130 minutes after Esketamine application
* Changes in oscillatory power within an experimental session pre/post Esketamine application * Power will be analyzed in canonical frequency bands (e.g. alpha, beta, gamma, delta, theta)
Change of Resting State EEG - Power in Session 2
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and130 minutes after Esketamine application
* Changes in oscillatory power within an experimental session pre/post Esketamine application * Power will be analyzed in canonical frequency bands (e.g. alpha, beta, gamma, delta, theta)
Change of Resting State EEG - Connectivity in Session 1
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
- Changes in functional connectivity in canonical frequency band within an experimental session pre/post Esketamine application
Change of Resting State EEG - Connectivity in Session 2
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
- Changes in functional connectivity in canonical frequency band within an experimental session pre/post Esketamine application
Change of Resting State EEG - Source in Session 1
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
- Changes in spatial distribution and source of electric activity in canonical frequency band within an experimental session pre/post Esketamine application
Change of Resting State EEG - Source in Session 2
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
- Changes in spatial distribution and source of electric activity in canonical frequency band within an experimental session pre/post Esketamine application
Change of Resting State EEG - Aperiodic Signal in Session 1
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
- Changes in slope and offset of the aperiodic EEG signal within an experimental session pre/post Esketamine application
Change of Resting State EEG - Aperiodic Signal in Session 2
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
- Changes in slope and offset of the aperiodic EEG signal within an experimental session pre/post Esketamine application
Change of Resting State EEG - Entropy in Session 1
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes in after Esketamine application
- Changes of entropy measured in Lempel-Ziv Complexity and mutual information within an experimental session pre/post Esketamine application
Change of Resting State EEG - Entropy in Session 2
Time frame: 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application
- Changes of entropy measured in Lempel-Ziv Complexity and mutual information within an experimental session pre/post Esketamine application
6 secondary outcomes
Change in Task EEG - Event Related Potential (ERP) in Session 1
Time frame: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Task EEG - Event Related Potential (ERP) in Session 2
Time frame: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Task EEG - Time Frequency Analysis in Session 1
Time frame: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Task EEG - Time Frequency Analysis in Session 2
Time frame: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Pupillometry in Session 1
Time frame: 30 minutes before Esketamine application and 100 minutes after Esketamine application
Change in Pupillometry in Session 2
Time frame: 30 minutes before Esketamine application and 100 minutes after Esketamine application
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Flavio Frohlich, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by University of North Carolina, Chapel Hill at 1 site 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 3 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Belief Updating in Session 1 (time frame: 10 minutes before Esketamine application compared to 2 hours after Esketamine application). The study lists 21 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 19 Sep 2024.