NCT06132581 Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression
| NCT ID | NCT06132581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida State University |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-01-24 |
| Primary Completion | 2026-07-31 |
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 72 participants in total. It began in 2024-01-24 with a primary completion date of 2026-07-31.
⚠ 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
Anhedonia, the inability to seek-out and experience pleasure, is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants. In our previous research, we found that anhedonia decreases goal-directed behavior and its related neural activity. In this study, we will investigate target engagement from five-consecutive days of stimulation for participants that are within a unipolar major depressive episode and also have high symptoms of anhedonia.
Eligibility Criteria
Inclusion Criteria: * Between the ages of 18 and 65 * Able to provide informed consent * Have normal to corrected vision * Willing to comply with all study procedures and be available for the duration of the study * Speak and understand English * Mild suicide risk as determined by the Hamilton Depression Rating Scale (HAM-D; less than 3 for the suicidality item) and non-existent or mild risk according to the Depression Symptom Index Suicidality Subscale (DSI-SS). * Patient Health Questionnaire (PHQ-8) greater than or equal to 8 prior to the first session * Snaith Hamilton Pleasure Scale (SHAPS) greater than 33 at the first session * A diagnosis of major depressive disorder on the Mini International Neuropsychiatric Interview for the DSM-V (MINI) Exclusion Criteria: * ADHD (currently under treatment) * Neurological disorders and conditions including, but not limited to history of epilepsy; seizures, except childhood febrile seizures; dementia; history of stroke; Parkinson's disease, multiple sclerosis, cerebral aneurysm; brain tumors * Medical or neurological illness or treatment for a medical disorder that could interfere with study participation. For example, unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment * Prior brain surgery * Any brain devices/implants including cochlear implants and aneurysm clips, cardiac pacemaker, or any other implanted electronic device * History of current traumatic brain injury * Pregnancy (for females) * Current severe substance use disorder * Claustrophobia * Based on the use of MRI, additional exclusion/inclusion criteria are considered. Note that many contraindications for stimulation are common with MRI and thus are not repeated. Participants must not have metal in the body that is ferrous, will be required to remove all jewelry, must not have tattoos on the face or neck, must refrain from wearing metal in clothing (underwire) or active gear (possibility of metallic microparticle technology), must not be a metal worker or have an eye injury involving metal. * Anything that in the opinion of the investigator would place the participant at increased risk or preclude the participant's full compliance with or completion of the study * DSM-V diagnosis of present moderate or severe substance use disorder or alcohol use disorder, and past severe substance use disorder or alcohol use disorder, or psychotic disorder within the last 12 months
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06132581 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying 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 NCT06132581 currently recruiting?
Yes, NCT06132581 is actively recruiting participants. Contact the research team at jriddle@fsu.edu for enrollment information.
Where is the NCT06132581 trial being conducted?
This trial is being conducted at Tallahassee, United States.
Who is sponsoring the NCT06132581 clinical trial?
NCT06132581 is sponsored by Florida State University. The trial plans to enroll 72 participants.