Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Naturalistic Intranasal Esketamine, Brief Cognitive Behavioral Therapy for Suicide Prevention.
- Who it may be relevant to
- Registry conditions: Suicidal Ideation. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Combined Intranasal Esketamine and Brief Cognitive Behavioral Therapy for Suicidal Ideation - A Randomized Controlled Trial
Overview
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.
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
Primary outcome measures
- Beck Scale for Suicidal Ideation [Time frame: 1-week post treatment]
- TMS-EEG N100 peak [Time frame: 1-week post treatment]
Secondary outcome measures (2)
- Suicidal Ideation Attributes Scale (SIDAS) [Time frame: 1-week post treatment]
- Columbia Suicide Severity Scale (C-SSRS) [Time frame: 1-week post treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UC San Diego Health - 4S Ranch — San Diego
Identifiers
NCT: NCT07396220 · 813122