Keck Medicine of USC expert leading clinical trial site in hopes of expanding access to cutting-edge treatment to patients

Carlos Figueroa, MD, Leads First-Ever Vagus Nerve Stimulation (VNS)
Trial Study in Los Angeles to Combat Treatment Resistant Depression

Depression may persist even with traditional treatments and medications. More than four in 10 people fail to successfully achieve complete relief from major depression with their first medication and one out of four people with depression have ‘treatment resistant’ depression, meaning they have tried several treatments without success. Those with treatment resistant depression have severe depression and are 98% more likely to be at risk for hospitalization compared to those with non-treatment resistant depression.

However, since 2005, vagus nerve stimulation (VNS) therapy has been approved by the Food and Drug Administration (FDA) as a safe and effective treatment option for treatment resistant depression. In fact, it has been tested in several research studies, including one at Keck Medical Center of USC with Carlos Figueroa, MD, psychiatrist with Keck Medicine of USC and clinical assistant professor in the Keck School of Medicine of USC’s Department of Psychiatry and the Behavioral Sciences.

As of March 31, 2022, Dr. Figueroa is leading the first site in Los Angeles in the clinical trial study at Keck Medical Center to provide additional evidence of the possible benefit of VNS therapy for patients with treatment resistant depression. This study, called the RECOVER study, is approved by Medicare and in partnership with many of the nation’s top experts in treatment resistant depression from nearly 100 other leading hospitals and medical centers across the United States.

“While VNS therapy is FDA-approved and prescribed for thousands of patients, the RECOVER study will offer patients the opportunity to participate in VNS therapy that is not typically covered by insurance,” said Dr. Figueroa. “We are always looking for ways to provide support and help for those with complex medical conditions and we hope the trial results reveal ways to better treat patients with treatment resistant depression to improve their quality of life.”

The active initial phase of the RECOVER study will last 12 months, followed by a longitudinal phase for 4 years. For those that are screened and participate in the study, a trained neurosurgeon will perform a short outpatient surgical procedure to place the VNS device under the skin above the left chest muscle and connected by leads to the left vagus nerve in the neck. Patients will be separated into two groups with the VNS device turned on at different times.

In a previous 5-year clinical study, VNS demonstrated a 68% response rate and a 43% remission rate in people with treatment resistant unipolar depression and bipolar depression.

“We want to offer the most effective treatment options for our patients, which is why we’re excited to be the first hospital in Los Angeles to start the trial study,” said Dr. Figueroa. “We hope to treat and provide needed data to better determine the effectiveness of using VNS for patients with treatment resistant depression, which may help increase access to this kind of treatment to patients who need it.”

To learn more about enrollment of the RECOVER study at Keck Medicine of USC, please contact Amanda Romano, research coordinator, at Amanda.Romano@med.usc.edu.

Keck Medicine of USC patients and Trojan family members can contact (800) USC-CARE (800-872-2273) to schedule an appointment with a mental health professional.

More information on the Department of Psychiatry and the Behavioral Sciences can be found on the departmental website.