Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT07396220
Status
Enrolling By Invitation

Conditions

  • Suicidal Ideation

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Naturalistic Intranasal Esketamine — OTHER
    Naturalistic Intranasal Esketamine is administered in accordance with psychiatrist recommendations
  • Brief Cognitive Behavioral Therapy for Suicide Prevention — BEHAVIORAL
    12 session evidence based psychotherapy protocol with weekly 50 minute sessions

Study Details

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.

Key Dates

Start date
Jan 9, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intranasal Esketamine
    Naturalistic Intranasal Esketamine
  • Experimental: BCBT-SP + Intranasal Esketamine
    Brief Cognitive Behavioral Therapy for Suicide Prevention combined with Intranasal Esketamine

Primary Outcome Measure

Beck Scale for Suicidal Ideation [ Time Frame: 1-week post treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Health - 4S RanchSan DiegoCalifornia92127-

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UC San Diego Health - 4S Ranch· San Diego, CA

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