HOPE Therapeutics Launches Patient Care With One-Day Ampa ONE-D Protocol For Treatment-Resistant Depression, Becoming First To Introduce The Technology In Florida

HOPE Therapeutics™, Inc., an interventional psychiatry network owned by NRx Pharmaceuticals, Inc., has announced the initiation of patient care using the Ampa one-day (ONE-D) protocol for the treatment of treatment-resistant depression. With this development, HOPE became the first organization to deploy the Ampa technology in Florida and among the earliest to introduce it nationwide, marking a significant step forward in the field of advanced mental health treatments.

The Ampa device represents a new approach to Transcranial Magnetic Stimulation (TMS) therapy. Unlike traditional TMS methods that typically require 90 days of treatment, the Ampa ONE-D protocol combines a single day of TMS therapy with the physician-prescribed use of D-cycloserine and lisdexamfetamine. In nonrandomized clinical trials, this approach demonstrated highly encouraging results, with an 87% response rate and 72% remission rate in patients suffering from severe depression. 

Although neither D-cycloserine nor lisdexamfetamine is FDA-approved for this specific indication, peer-reviewed studies have reported that D-cycloserine significantly enhances the effectiveness of TMS, improving outcomes in depression and reducing suicidality by more than twofold compared to placebo in traditional TMS protocols.

Recent findings from a research team led by Professor Joshua Brown at Harvard’s McLean Hospital, who also serves as President of the Clinical TMS Society, further support the synergistic effect of D-cycloserine in improving TMS efficacy. These results have strengthened the scientific foundation for HOPE’s deployment of the Ampa ONE-D protocol as a next-generation intervention for patients with severe and treatment-resistant depression.

The Ampa device is being rolled out across several HOPE clinic locations in Florida, including Sarasota, Naples, and Fort Myers, under the leadership of Dr. Rebecca Cohen, Medical Director at HOPE Therapeutics. The company plans to expand to six Florida locations by the end of 2025. This expansion aligns with HOPE’s mission to make innovative, evidence-supported treatments accessible to patients who have not responded to conventional therapies.

D-cycloserine, one of the active agents used in the protocol, is also a key component of NRX-101, a Breakthrough Therapy-designated investigational drug developed by NRx Pharmaceuticals. NRX-101 is currently available under an expanded access protocol and Right to Try regulations, enabling eligible patients to receive potentially life-changing treatment options while formal studies continue (ClinicalTrials.gov Identifier: NCT05779267).

Dr. Rebecca Cohen expressed optimism about the transformative potential of the new treatment approach, stating, “I am thrilled to be leading HOPE Therapeutics at a time when TMS is showing such dramatic and rapid results in patients with severe depression. The one-day Ampa ONE-D protocol represents a potential paradigm shift in how we treat depression—moving from months of therapy to weeks or even days of meaningful improvement. While further randomized, prospective studies are needed to confirm these results, the early findings are highly promising and could redefine how we view neuroplasticity and brain healing in depression treatment.”

Dr. Cohen added that HOPE remains committed to staying at the forefront of interventional psychiatry, focusing on depression and post-traumatic stress disorder (PTSD). “Our goal is to continue expanding access to innovative therapies and to make a difference for the estimated 13 million Americans who experience suicidal thoughts each year,” she said. 

Through its ongoing innovation and expansion, HOPE Therapeutics aims to revolutionize mental health treatment by offering faster, more effective, and patient-centered solutions for individuals living with severe and treatment-resistant depression.