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Brain Network Dynamics of Depression During Esketamine Treatment (K-BRAINED Trial)
Chapel Hill, NC
N/A
Waitlist Available
Led By Flavio Frohlich, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes before esketamine application compared to 2 hours after esketamine application
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates how Esketamine, a nasal spray for hard-to-treat depression, affects brain activity and belief updating. It aims to see if the medication helps people with depression think more positively and how this relates to changes in their brain function. Esketamine nasal spray has been approved for use in treatment-resistant depression and has shown rapid onset of antidepressant effects.
Eligible Conditions
- Major Depressive Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes before esketamine application and 100 minutes after esketamine application
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes before esketamine application and 100 minutes after esketamine application
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Belief Updating in Session 1
Change in Belief Updating in Session 2
Change in Confidence in Beliefs Questionnaire in Session 1
+18 moreSecondary study objectives
Change in Pupillometry in Session 1
Change in Pupillometry in Session 2
Change in Task EEG - Event Related Potential (ERP) in Session 1
+3 moreSide effects data
From 2018 Phase 3 trial • 226 Patients • NCT0303919235%
Dizziness
29%
Dissociation
20%
Nausea
19%
Somnolence
19%
Headache
17%
Blood Pressure Increased
14%
Dysgeusia
13%
Constipation
9%
Vision Blurred
7%
Vomiting
7%
Hypoaesthesia
6%
Insomnia
6%
Sedation
6%
Vertigo
5%
Dizziness Postural
5%
Anxiety
2%
Depression Suicidal
1%
Depression
1%
Diabetic Ketoacidosis
1%
Suicide Attempt
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus SOC Antidepressant Treatment
Esketamine 84 mg Plus SOC Antidepressant Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment Resistant Depression + Esketamine TreatmentExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esketamine nasal spray
2023
N/A
~10
Find a Location
Closest Location:Carolina Center for Neurostimulation· Chapel Hill, NC
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,580 Previous Clinical Trials
4,327,068 Total Patients Enrolled
Flavio Frohlich, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
19 Previous Clinical Trials
605 Total Patients Enrolled