ONE-D is the first reported protocol to achieve remission from treatment-resistant depression with a single day of treatment, using an FDA-cleared device.
HOPE Therapeutics, an interventional psychiatry network owned by NRx Pharmaceuticals, Inc. announced initiation of patient care with for treatment-resistant depression with the Ampa one day (ONE-D) protocol. HOPE is the first to deploy the Ampa technology in Florida and one of the first deployments nationwide. The Ampa device differs from other Transcranial Magnetic Stimulation (TMS) treatments in that the peer-reviewed literature has reported a high rate of success (87% response and 72% remission) in nonrandomized trials when a single day of TMS treatment is combined with physician-prescribed D-cycloserine and lisdexamfetamine (note that neither of the drugs reported in the published results is FDA-approved for the stated indication). D-cycloserine was previously reported to substantially enhance the effectiveness of TMS in reducing depression and suicidality by more than two-fold in a placebo-controlled trial using a traditional TMS protocol. Additional supportive findings documenting the effect of D-cycloserine in enhancing the effect of TMS were recently published by a team of researchers led by Prof. Joshua Brown at Harvard’s McLean hospital. Dr. Brown additionally serves as the President of the Clinical TMS Society.
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The Ampa device is initially deployed at multiple HOPE clinic locations in Florida including Sarasota, Naples and Fort Myers, under the direction of Rebecca Cohen, MD, HOPE’s Medical Director, with six locations in Florida planned by year-end 2025. The ONE-D protocol offers a new treatment paradigm to patients with severe depression who previously were required to undergo 90 days of TMS. D-cycloserine is an active component of NRX-101, a Breakthrough Therapy designated investigational drug that is available under an expanded access protocol and Federal and State Right to Try regulations.
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“I am thrilled to be assuming a leadership role in HOPE Therapeutics at a moment when TMS is suddenly demonstrating dramatic results for patients with potential to heal the brain in depression in weeks, rather than months, based on a one-day treatment protocol. Although the results reported by multiple leaders in the field of short-term TMS combined with neuroplastic drugs are not yet based on randomized, prospective data, they are promising and have the potential to change the paradigm of TMS therapy from a three month course of treatment to a far shorter and rapidly effective modality of care. The randomized prospective data demonstrating a greater than two-fold enhancement of the TMS effect when D-cycloserine is added represents a dramatic enhancement. We at HOPE aim to remain on the cutting edge of life transforming therapy for depression and PTSD and to rapidly expand to change the lives of the 13 million Americans who tragically contemplate suicide each year,” said Dr. Cohen.
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Source- GlobeNewswire
