Are you a Veteran? Have You Served in the US Military and Have Posttraumatic Stress Disorder (PTSD)? We are seeking men and women, at least 18 years old, diagnosed with PTSD from experiences that occurred …
Our study of MDMA-assisted psychotherapy for the treatment of PTSD in veterans of war is waiting for the FDA’s Controlled Substances Staff (CSS) to complete its review of the qualifications of the …
The FDA accepted our amendment to our protocol for MDMA-assisted psychotherapy for veterans of war with chronic, treatment resistant, PTSD. MAPS’ cover letter to the FDA 4-1-10 IRB Approval Letter …
We submitted an amendment to the IRB concerning our MDMA/PTSD study with veterans of war. Cover Letter Internal Sign-off.doc Final Protocol.pdf Summary of Changes.pdf Summary of Changes with Rationale.docx
Response to deferral letter.pdf Response to Deferral.pdf Cover Letter.pdf Protocol Document.pdf Subject Information and Consent Form.doc
The IRB deferred approval of our MDMA/PTSD veterans of war protocol.
We submitted our MDMA/PTSD veterans of war protocol to the IRB.
We have submitted the protocol (part 1, part 2, part 3) for our planned study of MDMA-assisted psychotherapy for the treatment of veterans of war with chronic posttraumatic stress disorder (PTSD) to the …
Were close to completing the protocol design for our upcoming U.S. MDMA/PTSD study exclusively for veterans of war. We plan to submit this protocol to the FDA in November 2009. A crucial protocol design …
The European Medicines Agency has recently issued guidelines for sponsors interested in developing drugs to treat PTSD. The PTSD guidelines suggest that research be conducted in subgroups of people with …
