Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07396220
Eligibility Criteria:
Inclusion Criteria:
1. All genders
2. Ages 18 to 70 years
3. Physician order of intranasal esketamine in the UCSD Interventional Psychiatry Clinic
4. 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)
5. Ongoing SI present beyond the screening phase of the study (confirmed with Beck SSI score ≥4).
6. Pass the TMS adult safety screening (TASS) questionnaire
7. Voluntary outpatients capable to consent to treatment and seen at the UC San Diego Health Interventional Psychiatry program.
8. Able to adhere to the treatment schedule.
Exclusion Criteria:
1. Previously undergone the Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) protocol
2. Currently undergoing an evidence based psychotherapy treatment (according to the policies by the American Psychological Association)
3. 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)
4. Not capable to consent to treatment or not suitable for outpatient treatment
5. 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.
6. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07396220
Study Brief:
Protocol Section:
NCT07396220