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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: 3, Interesting) by RamiK on Wednesday August 30 2017, @02:21PM (2 children)

    by RamiK (1813) on Wednesday August 30 2017, @02:21PM (#561508)

    This was years before personal computers. Not only was the hardware needed to run Unix too expensive to be within an individual's reach, but nobody imagined that would change in the foreseeable future. So Unix machines were only available by the grace of big organizations with big budgets: corporations, universities, government agencies. But use of these minicomputers was less regulated than the even-bigger mainframes, and Unix development rapidly took on a countercultural air. It was the early 1970s; the pioneering Unix programmers were shaggy hippies and hippie-wannabes. They delighted in playing with an operating system that not only offered them fascinating challenges at the leading edge of computer science, but also subverted all the technical assumptions and business practices that went with Big Computing. Card punches, COBOL, business suits, and batch IBM mainframes were the despised old wave; Unix hackers reveled in the sense that they were simultaneously building the future and flipping a finger at the system.

    http://www.faqs.org/docs/artu/ch02s01.html [faqs.org]

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  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @02:35PM (1 child)

    by Anonymous Coward on Wednesday August 30 2017, @02:35PM (#561511)

    Linux is the establishment and systemd is the flipping finger. Countercultural enough for you?

    • (Score: 3, Insightful) by Anonymous Coward on Wednesday August 30 2017, @04:23PM

      by Anonymous Coward on Wednesday August 30 2017, @04:23PM (#561555)

      I realise that you're being jocular, but:

      honestly, systemd is more like the establishment trying to worm its way into Linux. "It's too hard for the Marketing department guys! Just ... make all that complexity go away! Like Microsoft!"