VA Launches Psilocybin Trial for Veterans with Treatment-Resistant Depression

Clinical trial will evaluate effectiveness and safety of psilocybin to treat major depression in veterans, including those with concurrent post-traumatic stress disorder.

The U.S. Department of Veterans Affairs announced the launch of a novel clinical trial to assess the efficiency and safety of psilocybin to manage major depression in veterans, including those with concurrent post-traumatic stress disorder.

The novel trial comes after President Trump’s recent executive order on “Accelerating Medical Treatments for Serious Mental Illness,” which goal to highly clinical trial participation and speed up innovative research models and drug approvals for psychedelic medication.

VA’s trial is titled “Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression,” or PIVOT, and seeks to pursue innovative solutions for veterans who have not responded to existing treatments.

“Far too many veterans are living with mental health conditions that don’t respond to available treatments,” said VA Secretary Doug Collins. “VA is pursuing all avenues to evaluate new treatments and offer meaningful relief for those who have worn the uniform. This clinical trial reflects another step toward this goal.”

The randomized, controlled trial enroll veterans identified with management-resistant major depressive disorder, with or deprived of concurrent PTSD, and comparation results between two psilocybin dosage levels. The research will also assess participants’ levels of depression before and after management, tolerability of adverse effects, and overall patient-stated depression.

The trial conducted in five locations: Birmingham VA Health Care System and Tuscaloosa VA Medical Center in Alabama, VA Portland Health Care System in Oregon, Corporal Michael J. Crescenz VA Medical Center in Philadelphia and VA Puget Sound Health Care System in Seattle.

The trial conducted in a safe, controlled, healthcare setting using biopharmaceutical-grade therapeutics under careful quality controls, stringent safety protocols that were developed with FDA, and in a setting that involves psychological support.

Furthermore, to this trial, VA is involved in 20 active clinical trials focused on psychedelic treatments for mental medical conditions. All VA research involving research into psychedelics is conducted under strict safety protocols and in full compliance with government guidelines.

The U.S. Food and Drug Administration has granted breakthrough therapy designation to major companies developing psychedelic substances, involving MDMA, psilocybin and LSD, enabling for accelerated review of these drugs. Clinical applications of these therapies outside of research only be measured by VA once FDA approval is granted.

VA strongly discourages self-medicating or attempting to substitute other mental health treatment choice with psychedelics or any other unprescribed substances. Proven, evidence-driven management, are presently available at VA facilities to managing veterans with mental health conditions. Veterans always consult their medical care providers before creating any management decisions.

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About DNA Script

The VA is positioned to offers support, as suitable, with transportation; caregiver support; homelessness; pharmaceutical advantages; clothing allowances; counseling in readjustment centers; and a full range of physical, psychological, dental, and social solutions. VHA employs more than 14,000 physicians and nearly 300,000 other health care specialists. VHA mainly exists to offers healthcare to military veterans. Runs the largest integrated health care technology in U.S, managing hundreds of hospitals, hospitals, and chronic care centers.

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