Brain Network Dynamics of Depression During Esketamine Treatment

Status Recruiting

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06012916
Study type	Observational
Source	University of North Carolina, Chapel Hill
Contact	Tobias U Schwippel, MD
Phone	9199669929
Email	tobias_schwippel@unc.edu
Status	Recruiting
Phase
Start date	July 3, 2023
Completion date	August 30, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Brain Network Dynamics of Depression During Esketamine Treatment — K-BRAINED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms