NCT07896343 Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
| NCT ID | NCT07896343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Depression - Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-10 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-10 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to understand how the orbitofrontal cortex (OFC), a region at the front of the brain, guides decisions about whether to pursue a possible reward when doing so also carries a risk of loss, and how this process is altered in depression. People with depression are often less motivated by rewards and more sensitive to potential losses, leading them to avoid situations that others would approach. The OFC is thought to play a central role in these "approach or avoid" decisions, but how it normally does so, and what goes wrong in depression, is not well understood. This study asks two questions: (1) How does activity in different parts of the OFC signal the decision to approach or avoid? (2) Does this activity differ in people with depression in a way that explains a bias toward avoidance? We hypothesize that the medial OFC (toward the middle of the brain) signals approach, the lateral OFC (toward the side of the brain) signals avoidance, and that in depression the medial OFC signal is weakened, tipping decisions toward avoidance. Participants are adults who are hospitalized with stereo-EEG (sEEG) electrodes already placed in the brain by their medical team, either to locate the source of seizures in epilepsy or as part of a separate clinical trial for treatment-resistant depression. The electrodes are placed for clinical reasons only, not for this study. During their hospital stay, participants complete a short, game-like computer task (about 20 minutes per session) in which they repeatedly choose whether to approach or avoid options that offer different chances of reward and loss. Their choices and reaction times are recorded along with brain activity from the existing electrodes, and participants rate their mood before each session. The researchers will compare OFC activity during approach versus avoid decisions, use mathematical models of decision-making to measure how strongly each participant weighs rewards and losses, and compare participants with and without depression. No drugs, devices, or brain stimulation are given as part of this study. The findings are intended to guide the development of more targeted brain-stimulation treatments for treatment-resistant depression.
Eligibility Criteria
Inclusion Criteria: All participants: * 18 years of age or older * Implanted with stereo-EEG (sEEG) depth electrodes, including at least one electrode in the orbitofrontal cortex (OFC) * Able to read, write, and provide informed consent Depressed cohort: * Enrolled in the PRESIDIO trial (NCT04004169) of deep brain stimulation for treatment-resistant depression and undergoing inpatient sEEG monitoring as part of that trial * Meets DSM-5 criteria for major depressive disorder (single episode of at least 2 years' duration, or recurrent), without psychotic features, confirmed by structured clinical interview (e.g., MINI) Control (non-depressed) cohort: * Undergoing inpatient sEEG monitoring for a clinical indication other than depression (e.g., seizure localization in refractory epilepsy) * No current diagnosis of major depressive disorder, confirmed by clinical psychiatric evaluation (e.g., MINI and symptom scales) Exclusion Criteria: All participants: * Current or past DSM-5 diagnosis of a psychotic disorder or major depressive disorder with psychotic features * Current or past DSM-5 diagnosis of bipolar or related disorder * Current obsessive-compulsive disorder * Intellectual disability * Autism spectrum disorder * Borderline, antisocial, histrionic, or narcissistic personality disorder * Impaired decision-making capacity or cognitive deficits that preclude informed consent or task completion * Employee of the investigator or study site with direct involvement in the study, or family member of the investigator Control (non-depressed) cohort only: \* Epileptiform abnormalities involving the OFC, OFC dysplasia, or prior OFC resection, as determined by clinical evaluation and imaging
Contact & Investigator
Andrew Krystal, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07896343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07896343 currently recruiting?
Yes, NCT07896343 is actively recruiting participants. Contact the research team at clara.starkweather@ucsf.edu for enrollment information.
Where is the NCT07896343 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07896343 clinical trial?
NCT07896343 is sponsored by University of California, San Francisco. The principal investigator is Andrew Krystal, MD at University of California, San Francisco. The trial plans to enroll 10 participants.
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