Brain Network Dynamics of Depression During Esketamine Treatment

This observational clinical trial (n=100), conducted by the University of North Carolina, Chapel Hill, aims to investigate the effects of esketamine nasal spray on brain network activity and belief updating in individuals with major depressive disorder (MDD).

Esketamine, the S-enantiomer of Ketamine, was approved by the FDA in 2019 for treatment-resistant depression. The study seeks to understand the immediate and long-term effects of Esketamine on EEG signals, pupillometry, and belief updating, and their relation to depressive symptoms.

The trial focuses on assessing how Esketamine affects cognitive processes such as belief updating, using the Belief Updating Task (BUT), which measures changes in expectations of future life events in response to new information. The study examines whether Esketamine treatment reinstates an optimistic belief update bias in individuals with depression and how these changes correlate with neurophysiological changes during the task and alterations in depressive symptoms.

Participants in the study are adults diagnosed with MDD who are undergoing treatment with Esketamine nasal spray. The trial involves recording EEG and pupillometry measurements before and after Esketamine administration, as well as cognitive tasks and self-scored questionnaires on depressive symptoms and treatment expectations. Clinical information is also collected from medical records.

The primary outcome measures include changes in belief updating, confidence in beliefs, ketamine side effects, mood, quality of life, and depression severity. Secondary outcome measures include event-related potentials (ERPs), time-frequency analysis, and pupillometry during cognitive tasks.

The study is designed as an observational case-only trial with a prospective time perspective. It started on July 3, 2023, and is estimated to be completed by August 30, 2024, with an enrollment target of 100 participants. The trial is conducted at the Interventional Psychiatry outpatient clinic at the University of North Carolina at Chapel Hill.

Topic Depression
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 03 July 2023
End date 30 August 2024
Design Open
Type Observational
Generation Second
Participants 100
Sex All
Age 18- 99
Therapy No

Trial Details

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.

Trial Number NCT06012916

Data attribution

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