Behavioral Health Clinical Trials
You may be eligible to participate in behavioral health clinical trials through UNC Health Rex. These studies evaluate the effectiveness of tests, treatments or approaches to care that aren’t yet widely available.
Now Enrolling: New Behavioral Health Clinical Trials at UNC Health Rex
UNC Health Rex Hospital is proud to be enrolling participants in two newly awarded Phase 2 clinical trials led by Dr. Sandeep Vaishnavi. These studies provide patients in our community with access to innovative research opportunities while helping advance the development of future treatments for behavioral health and neurological conditions.
GATE-251 is a Phase 2 clinical trial evaluating zelquistinel, an investigational oral medication, for the treatment of major depressive disorder (MDD) in adults. The study is designed to assess the medication's safety and effectiveness in reducing symptoms of depression compared with placebo.
ClinicalTrials.gov:
Study Details | NCT06547489 | Zelquistinel or Placebo for the Reduction of Symptoms of Major Depres…
BALANCE-AAD-1 (IM045-P06) is a Phase 2 clinical trial evaluating BMS-986368, an investigational FAAH/MAGL inhibitor, for the treatment of agitation associated with Alzheimer's disease. The study is designed to assess the medication's safety, tolerability, and effectiveness in reducing agitation symptoms compared with placebo.
ClinicalTrials.gov:
Study Details | NCT06808984 | Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-98636…
If you or a loved one may be interested in participating in either study, we encourage you to learn more about these research opportunities. To determine eligibility or ask questions, please contact the UNC Health Rex research team at
uncrexresearch@unchealth.unc.edu
or 919-784-1092.
Behavioral health research at UNC Health Rex with Dr. Vaishnavi
Sandeep Vaishnavi, MD, PhD
Physician Lead, Behavioral Health Research, UNC Health Medical Group
Dr. Vaishnavi is board-certified in Psychiatry and is also certified in Behavioral Neurology & Neuropsychiatry. He has a PhD in Cognitive Science, with a specialization in Cognitive Neuroscience. He is a Fellow of the American Neuropsychiatric Association and has been selected a Castle Connolly Top Doctor. He is the co-author of the best-selling book, The Traumatized Brain: A Family Guide to Understanding Mood, Memory, and Behavior after Brain Injury.
Dr. Vaishnavi has participated in pivotal studies that have led to FDA approval for brexpiprazole for agitation in Alzheimer's Disease, as well as FDA clearances for the digital therapeutic EndeavorRx for ADHD in children, adolescents, and adults. He was part of the pivotal study that led to the FDA clearance of the digital therapeutic Rejoyn for major depressive disorder. He was also part of the pivotal study that led to FDA clearance for Magnetic EEG-Guided Resonance Therapy (MeRT), a form of transcranial magnetic stimulation, for PTSD.
To learn more about the clinical trials Dr. Vaishnavi has conducted at UNC Health Rex, please contact
uncrexresearch@unchealth.unc.edu
.
UNC Health Rex Contributes to Groundbreaking PTSD Treatment Advancement
UNC Health Rex is proud to have participated in the pivotal clinical trial that supported the recent FDA clearance of Magnetic EEG Resonance Therapy (MeRT) as an adjunctive treatment for Post-Traumatic Stress Disorder (PTSD).
Led locally by Dr. Sandeep Vaishnavi, in partnership with the UNC Health Office of Clinical Research and Rex Neurodiagnostic EEG technicians, UNC Health Rex was the only site in the Southeast to participate in this multicenter, randomized, double-blind, sham-controlled trial. The study evaluated MeRT, an innovative, personalized form of transcranial magnetic stimulation (TMS) that uses a patient's EEG brain wave activity to guide treatment.
This milestone highlights UNC Health Rex's commitment to advancing community-based clinical research and expanding access to innovative therapies close to home. Through collaboration among clinical, research, and operational teams, Rex continues to play a leading role in bringing cutting-edge treatment opportunities to patients across North Carolina.
