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Psychedelic treatments for trauma-related disorders are the use of psychedelic substances, either alone or used in conjunction with psychotherapy, to treat trauma-related disorders. [1] Trauma-related disorders, such as post-traumatic stress disorder (PTSD), have a lifetime prevalence of around 8% in the US population. [ 2 ]
[12] [15] The United States Food and Drug Administration has granted "breakthrough therapy" status, which expedites the potential approval of promising drug therapies, [note 2] to psychedelic therapies using psilocybin (for treatment-resistant depression and major depressive disorder) [6] and MDMA (for post-traumatic stress disorder). [17]
Federal health regulators on Friday declined to approve the psychedelic drug MDMA as a therapy for PTSD, a major setback for groups seeking a breakthrough decision in favor of using mind-altering ...
In June, the FDA's Psychopharmacologic Drugs Advisory Committeevoted 9-2 against MDMA as an effective treatment for PTSD patients, and 10-1 that the drug's benefits do not outweigh the risks.
The FDA review is part of a larger look into the potential use of psychedelic drugs for conditions that are typically difficult to treat, including depression and addiction.
A phase III study indicated that MDMA-assisted therapy represents a potential breakthrough treatment for severe PTSD that merits expedited clinical evaluation. [17] Based on this study, MDMA-assisted psychotherapy was granted breakthrough therapy designation by the FDA, a designation that indicates that there is preliminary evidence that an intervention might offer a substantial improvement ...
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