Suicidal IdeationPIK-SINCT07396220
Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation
A study testing Naturalistic Intranasal Esketamine and Brief Cognitive Behavioral Therapy for Suicide Prevention in people with Suicidal Ideation, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Naturalistic Intranasal Esketamine and Brief Cognitive Behavioral Therapy for Suicide Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UC San Diego Health - 4S Ranch
San Diego, California, 92127
About this study
Official title: Combined Intranasal Esketamine and Brief Cognitive Behavioral Therapy for Suicidal Ideation - A Randomized Controlled Trial
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
- Being tested
- Naturalistic Intranasal Esketamine, Brief Cognitive Behavioral Therapy for Suicide Prevention
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturalistic Intranasal EsketamineOther
Naturalistic Intranasal Esketamine is administered in accordance with psychiatrist recommendations
Brief Cognitive Behavioral Therapy for Suicide PreventionBehavioural
12 session evidence based psychotherapy protocol with weekly 50 minute sessions
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Esketamine | Active comparator | Naturalistic Intranasal Esketamine Receives: Other: Naturalistic Intranasal Esketamine |
| BCBT-SP + Intranasal Esketamine | Experimental | Brief Cognitive Behavioral Therapy for Suicide Prevention combined with Intranasal Esketamine Receives: Other: Naturalistic Intranasal Esketamine; Behavioral: Brief Cognitive Behavioral Therapy for Suicide Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Scale for Suicidal Ideation
Measured: 1-week post treatment
TMS-EEG N100 peak
Measured: 1-week post treatment
Secondary outcomes (2)
Suicidal Ideation Attributes Scale (SIDAS)
Measured: 1-week post treatment
Columbia Suicide Severity Scale (C-SSRS)
Measured: 1-week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start9 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cory Weissman, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396220
- Sponsor's protocol ID
- 813122
- Acronym
- PIK-SI
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Intranasal Esketamine and Brief Cognitive Behavioral Therapy for Suicidal Ideation - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07396220
- Acronym / sponsor ID
- PIK-SI / 813122
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Esketamine | Active comparator | Other: Naturalistic Intranasal EsketamineNaturalistic Intranasal Esketamine |
| BCBT-SP + Intranasal Esketamine | Experimental | Other: Naturalistic Intranasal Esketamine, Behavioral: Brief Cognitive Behavioral Therapy for Suicide PreventionBrief Cognitive Behavioral Therapy for Suicide Prevention combined with Intranasal Esketamine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naturalistic Intranasal EsketamineNaturalistic Intranasal Esketamine is administered in accordance with psychiatrist recommendations | Other | BCBT-SP + Intranasal Esketamine, Intranasal Esketamine |
| Brief Cognitive Behavioral Therapy for Suicide Prevention12 session evidence based psychotherapy protocol with weekly 50 minute sessions | Behavioural | BCBT-SP + Intranasal Esketamine |
Primary outcome
Beck Scale for Suicidal Ideation
Time frame: 1-week post treatment
TMS-EEG N100 peak
Time frame: 1-week post treatment
2 secondary outcomes
Suicidal Ideation Attributes Scale (SIDAS)
Time frame: 1-week post treatment
Columbia Suicide Severity Scale (C-SSRS)
Time frame: 1-week post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naturalistic Intranasal Esketamine and Brief Cognitive Behavioral Therapy for Suicide Prevention in people with Suicidal Ideation, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Scale for Suicidal Ideation (time frame: 1-week post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.