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An investigative, add-on MDMA-based therapy was effective for improving posttraumatic stress disorder (PTSD) symptoms, according to a phase III trial.

In a randomized controlled trial of 90 adults with severe chronic PTSD, those on MDMA pharmacotherapy plus psychotherapy saw a significant improvement in PTSD symptoms as measured by the clinician-administered Total Severity Score versus those on placebo and psychotherapy alone (d=0.91, 95% CI 0.44-1.37, P<0.0001), reported Jennifer Mitchell, PhD, of the University of California San Francisco, and colleagues.

After a full course of treatment, the MDMA and psychotherapy group saw an average drop in CAPS-5 score of 24.4 points, while those receiving psychotherapy alone saw an average drop of 13.9 points, they reported at the American Psychiatric Association (APA) virtual annual meeting.

In addition, participants in the MDMA-assisted psychotherapy group also saw a significant improvement in functional impairment, marked by a decrease in total score (d=0.43, 95% CI -0.01 to 0.88, P=0.0116).

And symptoms of depression were improved among the MDMA-assisted psychotherapy group, as measured by a near 20-point improvement in scores by the end of treatment, the researchers reported.

In September 2017, the to 3,4-methylenedioxymethamphetamine (MDMA) for treatment of PTSD when administered as an adjunct treatment to psychotherapy.

This trial randomized 46 individuals to the MDMA-assisted therapy group, which consisted of three 8-hour psychotherapy sessions where the participants took between 80 to 120 mg of oral MDMA with an additional half dose after 1.5 to 2 hours into the psychotherapy session.

They were then compared with 44 participants, who were administered placebo during the experimental sessions. All participants also underwent three 90-minute preparatory psychotherapy sessions led by a two-therapist person team prior to the experimental sessions, which were held about 4 weeks apart.

Following each session, the participants underwent a 90-minute integration sessions structured for the individual to greater understand their experience during the experimental portion.

The psychotherapy sessions were conducted according to the .

"This protocol and the associated statistical analysis plan were designed under a special protocol assessment with the FDA," Mitchell explained in an e-poster presentation.

After recruitment, all participants completed the DSM-5 PTSD checklist, including the , plus the .

Additionally, all participants under a thorough medical history, physical examination, and laboratory testing, as well as an EKG prior to beginning the psychiatric medication.

The average age of the participants was 41; the majority were female and white with an average 14-year duration of PTSD. About 82% had comorbid major depression. While the vast majority of participants had reported experiencing multiple traumas, the most commonly reported trauma was developmental trauma (76%), followed by being a veteran (16%), and combat exposure (11%).

"In accordance with FDA guidance, we paid special attention to a subset of adverse events [AEs]," Mitchell pointed out, explaining that these were dubbed "diverse events of special interest," which were related to cardiac arrhythmias, abuse, and liability, as well as suicidal ideation and behaviors.

MDMA was well-tolerated, as there wasn't any increase in suicidal ideation, abuse potential, or QT prolongation in this group. Only three serious AEs were reported during the trial -- all of which were reports of suicidal ideation -- each occurring in the placebo group. No deaths occurred.

The most common side effects reported during treatment were muscle tightness, decreased appetite, and nausea.

Overall, by the end of the third experimental session, 30% (n=14) of those in the MDMA group achieved PTSD remission, 60% achieved a loss of diagnosis, and 80% of the group were considered responders to treatment. On the other hand, less than 5% (n=2) of those receiving placebo with therapy were able to achieve PTSD remission by the end of the third session, with only half responding to treatment.

"MDMA was equally effective in participants with comorbidities that are often associated with treatment resistance, and there was no obvious impact of SSRI history on effectiveness of MDMA," Mitchell concluded.

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