NCT07396220

Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Suicidal Ideation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-09
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States