Psychedelic science: How LSD could reshape anxiety treatment

Researchers have conducted a rigorous clinical trial examining LSD as a treatment for generalized anxiety disorder, with results published in the Journal of the American Medical Association showing promising outcomes for patients who have struggled to find relief with existing medications.Cleveland Clinic psychiatrist Dr. Brian Barnett, who participated in the multi-site study, says the findings address a critical gap in mental health treatment. About one-third of patients with psychiatric conditions don't respond to any existing treatments, affecting millions of Americans with depression, anxiety and other disorders."Our existing treatments, there's a little variability depending on the particular condition, but generally about a third of patients with a particular condition will not respond to any psychiatric treatment," said Barnett. "So, when you think about that at scale, that's millions of people who have depression, anxiety, bipolar disorder that's not responding to treatment."The Phase 2b study, conducted by Mind Medicine Inc., involved 198 adults with moderate-to-severe generalized anxiety disorder across 22 psychiatric research sites in the United States. Participants received a single dose of MM120, a pharmaceutical-grade form of LSD, at varying strengths or a placebo.The most effective dose, 100 micrograms, showed significant improvements in anxiety symptoms that lasted throughout the 12-week observation period. Patients receiving this dose experienced a 7.6-point greater reduction in anxiety scores compared to those taking placebo, with 65% showing clinical response and 48% achieving clinical remission by week 12."About half of people were in remission from their generalized anxiety disorder 12 weeks after receiving a 100 microgram dose, so they no longer met criteria for generalized anxiety disorder," Barnett explained in an interview with WKYC's Monica Robins. "It's pretty impressive findings.""This study is a true turning point in the field of psychiatry," said Dr. Maurizio Fava, study author and Chair of Mass General Brigham Department of Psychiatry. "For the first time, LSD has been studied with modern scientific rigor, and the results are both clinically meaningful and potentially paradigm-shifting for the treatment of GAD."While researchers aren't entirely sure how psychedelics work therapeutically, Barnett explains they're believed to activate certain brain receptors and enhance neuroplasticity, making it easier for patients to learn new behaviors and thought patterns.The treatment showed results that appeared twice as effective as traditional medications like Prozac or Xanax when compared to historical studies, though Barnett cautions that direct head-to-head comparisons would be needed to confirm this finding.Generalized anxiety disorder affects approximately 26 million American adults, causing persistent worry that interferes with daily activities. Current first-line treatments fail about 50% of patients, and no new medications have been approved for the condition since 2007.Safety protocols for the study were extensive. About 90% of people with generalized anxiety disorder wouldn't qualify for these trials due to medical conditions like heart problems or history of bipolar disorder that could make psychedelic treatment risky."Safety is our number one priority in these trials," Barnett said. "We know that drugs like LSD are extremely powerful drugs, and if we're going to use them in medicine, then we have to do everything that we can to control the experience."During treatment sessions, participants are continuously monitored by two trained staff members in a controlled medical setting. Emergency medications are available if needed, though no serious adverse events occurred in the trials Barnett has conducted."There will never be a point where the FDA is going to approve sending psychedelics home with people," he emphasized. "They are drugs with strong psychoactive effects, so that's something we take very seriously."Side effects were consistent with LSD's known perceptual effects, including visual changes and nausea, occurring primarily on the day of treatment. Most adverse events were rated as mild-to-moderate and temporary.Based on these results, the FDA has granted Breakthrough Therapy Designation to MM120 for generalized anxiety disorder.Cleveland Clinic is currently enrolling patients for the Phase 3 trials, targeting 10 to 20 participants locally among several hundred nationwide. The trials will follow patients for a full year and allow multiple doses if needed, providing crucial information about how long benefits last.Many participants in the Phase 2 study eventually returned to traditional antidepressants, but often not until a year or more later, suggesting the psychedelic treatment provided substantial lasting benefits.Barnett doesn't consider this a "cure" for anxiety, noting that symptoms may return over time as they do with other psychiatric treatments. However, ...