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posted by cmn32480 on Wednesday August 30 2017, @01:38PM   Printer-friendly
from the and-the-side-effects-are.... dept.

The U.S. Food and Drug Administration has given its approval for Phase 3 trials to treat participants with PTSD using MDMA ("ecstacy"):

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.

MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct. By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.

The first Phase 3 trial (MAPP1), "A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder," will begin enrolling subjects in Spring 2018, after the completion of an open-label lead-in training study at Phase 3 sites starting this fall.

[...] The Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

In MAPS' completed Phase 2 trials with 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.

Also at ScienceAlert, the Washington Post, and Science Magazine:

Since 2012, FDA has designated close to 200 drugs as breakthrough therapies, a status that indicates there's preliminary evidence that an intervention offers a substantial improvement over other options for a serious health condition. The agency aims to help develop and review these treatments faster than other candidate drugs.

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  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @01:55PM (4 children)

    by Anonymous Coward on Wednesday August 30 2017, @01:55PM (#561499)

    Too lazy to cite, but I vaguely recall some research somewhere indicating that symptoms of depression appeared immediately following administration of LSD. Given how much it messes with serotonin, it sounded reasonable. That will likely put a damper on any future research on LSD as a kind of therapy, at least without some kind of pairing with SSRIs of some sort after the "session".

  • (Score: 3, Informative) by Scottingham on Wednesday August 30 2017, @02:42PM

    by Scottingham (5593) on Wednesday August 30 2017, @02:42PM (#561518)

    That's odd, I've heard the exact opposite with LSD. Though I too am too lazy to cite.

    Are you perhaps confusing it with the after-effects of MDMA? That is definitely associated, especially in an uncontrolled setting with an unknown dosage, symptoms of depression.

  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @03:25PM (1 child)

    by Anonymous Coward on Wednesday August 30 2017, @03:25PM (#561532)

    Too lazy to cite, but I vaguely felt the symptoms of thinking you're a dumbass set in after reading your comment.

    • (Score: 2) by edIII on Wednesday August 30 2017, @09:26PM

      by edIII (791) on Wednesday August 30 2017, @09:26PM (#561739)

      Oh no. I think it's contagious.

      Technically, lunchtime is at any moment. It's just a wave function.
  • (Score: 3, Interesting) by takyon on Wednesday August 30 2017, @04:07PM

    by takyon (881) <> on Wednesday August 30 2017, @04:07PM (#561548) Journal

    You're thinking of MDMA, the very drug this story is about. To counter that, you take 5-HTP [] to restore serotonin levels.

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