Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07396220

Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego Health - 4S Ranch

San Diego, California, 92127, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All genders
  • Ages 18 to 70 years
  • Physician order of intranasal esketamine in the UCSD Interventional Psychiatry Clinic
  • Treatment resistant depression diagnosis confirmed by the ordering physician (treatment failure defined as the lack of clinically meaningful response in depression following an antidepressant trial)
  • Ongoing SI present beyond the screening phase of the study (confirmed with Beck SSI score ≥4).
  • Pass the TMS adult safety screening (TASS) questionnaire
  • Voluntary outpatients capable to consent to treatment and seen at the UC San Diego Health Interventional Psychiatry program.
  • Able to adhere to the treatment schedule.

Exclusion criteria

  • Previously undergone the Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) protocol
  • Currently undergoing an evidence based psychotherapy treatment (according to the policies by the American Psychological Association)
  • Presence of SI prompting emergent hospital stay (SI in which the participant can maintain voluntary and capable as an outpatient, as well as recent suicide attempt, will not be exclusionary)
  • Not capable to consent to treatment or not suitable for outpatient treatment
  • Have a cardiac pacemaker or implanted medication pump; any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy, cerebral aneurysm, significant head trauma with loss of consciousness for greater than 5 minutes; Have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
  • Based on eligibility for Intranasal Esketamine in the UCSD IPP clinic: Lifetime diagnosis of bipolar I or II disorder or schizophrenia spectrum disorder or current diagnosis of a substance use disorder or cognitive disorder documented in the electronic medical records

Treatment and study plan

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

Primary outcomes

  1. Beck Scale for Suicidal Ideation

    Time frame: 1-week post treatment

  2. TMS-EEG N100 peak

    Time frame: 1-week post treatment

Secondary outcomes

  1. Suicidal Ideation Attributes Scale (SIDAS)

    Time frame: 1-week post treatment

  2. Columbia Suicide Severity Scale (C-SSRS)

    Time frame: 1-week post treatment

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Acronym: PIK-SI

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.