Progress in Neuro-Psychopharmacology & Biological
Psychiatry said:
2.2. MDMA-assisted therapy for PTSD
The first placebo-controlled Phase 2 pilot study of MDMA-assisted
psychotherapy for the treatment of chronic, treatment resistant PTSD
demonstrated promising results in a sample of 20 subjects (Mithoefer
et al., 2011). Scores on the Clinician-Administered PTSD Scale (CAPS),
an established gold-standard measure of PTSD symptoms, declined to
a statistically and clinically significant degree after undergoing
MDMA-assisted psychotherapy. The group of subjects randomized to
receive MDMA showed a mean CAPS score reduction of 53.7, with a
mean starting score of 79.2, whereas, participants in the placebo arm
who also received psychotherapy had a mean starting score of 79.6
and showed a mean CAPS score reduction of 20.5. As a point of compar-
ison, a reduction of mean CAPS scores of 10.2 in a clinical trial of 187 pa-
tients resulted in FDA-approval of sertraline (Zoloft) for PTSD (Brady
et al., 2000). Improvements in PTSD symptoms observed in the proof
of principle study were maintained an average of 3.8 years later (N =
16) (Mithoefer et al., 2013). Mithoefer et al., (2011) reported that,
“MDMA-assisted psychotherapy with close follow-up monitoring and
support can be used with acceptable and short-lived side effects in a
carefully screened group of subjects with chronic, treatment-resistant
PTSD” (p. 449). A double blind pilot study of MDMA-assisted psycho-
therapy conducted by a Swiss therapist team in an equivalent Swiss
clinical population (N = 12) comparing 125 mg MDMA to 25 mg
MDMA as an active placebo found a clinically but not statistically signif-
icant effect, although trends toward symptomatic improvement were
noted using a German translation of the CAPS (Oehen et al., 2013).
The improvement continued to increase during the twelve-month
follow-up.
Currently, four Phase 2 pilot studies of MDMA-assisted psychother-
apy are underway for treatment of chronic PTSD (NCT01689740,
NCT01793610, NCT01211405, NCT01958593), including one in trauma-
tized war veterans and as well as first responders, such as police officers
and fire fighters. These studies have shown promise for MDMA-assisted
psychotherapy to help people overcome PTSD, an anxiety-related disor-
der, and suggest that this treatment could also be useful in treating so-
cial anxiety in autistic adults.
