Skip to content
lsd.com
CompletedN/A

Brain Network Dynamics of Depression During Esketamine Treatment

NCT06012916 · K-BRAINED · University of North Carolina, Chapel Hill

Closed to entry
Status
Not accepting participants
Not applicable
Phase
8
Target enrolment
1
Study sites
1 US states

What it is testing

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. 8 weeks) of Esketamine on EEG signals, pupillometry and belief updating and the relation of those effects on depressive symptomatology.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Belief Updating in Session 1

    Measured over 10 minutes before Esketamine application compared to 2 hours after Esketamine application

  • Change in Belief Updating in Session 2

    Measured over 10 minutes before Esketamine application compared to 2 hours after Esketamine application

  • Change in Confidence in Beliefs Questionnaire in Session 1

    Measured over 30 minutes before Esketamine application compared to 2 hours after Esketamine application

  • Change in Confidence in Beliefs Questionnaire in Session 2

    Measured over 30 minutes before Esketamine application compared to 2 hours after Esketamine application

  • Change of Ketamine Side Effect Tool (KSET) in Session 1

    Measured over 5 minutes before Esketamine application, and 50, 95, and 130 minutes after Esketamine application

  • Change of Ketamine Side Effect Tool (KSET) in Session 2

    Measured over 5 minutes before Esketamine application, and 50, 95, and 130 minutes after Esketamine application

  • Change in Mood Likert Scale in Session 1

    Measured over 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

    Measured over 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)

    Measured over Session 1 and session 2

  • Change in Patient Health Questionnaire (PHQ-9)

    Measured over Session 1 and session 2

  • Change in Hamilton Depression Rating Scale (HDRS)

    Measured over Session 1 and session 2

  • Change of Resting State EEG - Power in Session 1

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over 5 minutes before Esketamine application, and 15, 35, 50, 75, 95, and 130 minutes after Esketamine application

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 99 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Major Depressive Disorder * Receiving Esketamine nasal spray treatment for depression * Ability to understand study procedures and sign an informed consent. Exclusion Criteria: * None

Where

1 study site

FacilityCityRegionCountry
Carolina Center for NeurostimulationChapel HillNorth CarolinaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06012916 on ClinicalTrials.gov →

Last updated in the registry 2024-09-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 2 trials from University of North Carolina, Chapel Hill →