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ENROLLING BY INVITATION
NCT07396220
NA

Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

Summary

The purpose of this study is to examine the effects of combined intranasal esketamine with brief cognitive behavioral therapy for suicide prevention (BCBT-SP) for suicidal ideation (SI) in patients with treatment- resistant depression (TRD). The secondary aim is to identify the biological targets of treatment response using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG). In this project we will recruit patients between the ages of 18 and 70, diagnosed with a major depressive episode with ongoing suicidal ideation present who have failed (or not shown signs of improvement) after at least one prior treatment. The null hypothesis is that there will be no difference in reductions in suicidality at 1-week post-treatment between the combined treatment group and the ketamine only treatment group. The alternative hypothesis is that the combined treatment will result in a greater reduction in suicidal ideation at 1-week post-treatment.

Official title: Combined Intranasal Esketamine and Brief Cognitive Behavioral Therapy for Suicidal Ideation - A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-01-09

Completion Date

2029-01

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

OTHER

Naturalistic Intranasal Esketamine

Naturalistic Intranasal Esketamine is administered in accordance with psychiatrist recommendations

BEHAVIORAL

Brief Cognitive Behavioral Therapy for Suicide Prevention

12 session evidence based psychotherapy protocol with weekly 50 minute sessions

Locations (1)

UC San Diego Health - 4S Ranch

San Diego, California, United States