Switzerland News Timeline

Switzerland Study: Researcher Claims Study Showed Large Treatment Effect, Not Small

On August 27, 2013, the Journal of Psychopharmocology published a Letter to the Editor arguing that our completed Swiss study of MDMA-assisted psychotherapy for PTSD had a large effect size not previously reported in the January 2013 publication of the results in the same journal. In the unsolicited yet most welcome letter, "MDMA-assisted psychotherapy found to have a large effect for post-traumatic stress disorder," researcher Henri Chabrol of the University of Toulouse, France, explains why our traditional statistical method should have been supplemented by an effect size calculation, and that in fact subjects showed "on average, a substantial improvement in PTSD symptoms over the course of MDMA-assisted psychotherapy." Receiving this unsolicited positive feedback on our results from an independent expert highlights both the importance of international collaboration in psychedelic research and the sincere caution with which we report our results. View the letter | Download the original paper

Switzerland Study: Results Published in Journal of Psychopharmacology

On January 1, 2013, the results from our now-completed Swiss pilot study of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD became published in the Journal of Psychopharmacology, a peer-reviewed scientific journal. The paper, co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies, the world’s largest organization for PTSD treatment providers and researchers, describes clinically (and almost statistically) significant decreases in PTSD symptoms following MDMA-assisted psychotherapy.

Switzerland Study: Results Accepted for Publication in Journal of Psychopharmacology

On September 21, 2012, the paper describing the results of our completed Swiss Phase 2 pilot study of MDMA-assisted psychotherapy in 12 subjects with chronic, treatment-resistant PTSD was accepted for publication in the Journal of Psychopharmacology. The paper, co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies, the world’s largest organization for PTSD treatment providers and researchers, describes clinically (and almost statistically) significant decreases in PTSD symptoms following MDMA-assisted psychotherapy.

While the small number of subjects in the study contributed to the results approaching but not reaching statistical significance, the mean reductions in PTSD scores were larger than those found in the clinical studies leading to FDA approval for Paxil and Zoloft, the only two currently approved medications for PTSD. Additionally, we were able to generate a successful double blind with therapists and patients both making numerous incorrect guesses about which dose of MDMA had been administered. The paper will be published and available online in February 2013.

Switzerland Study: Results Submitted for Publication in Peer-Reviewed Journal

On February 27, 2012, the lead investigator for our now-completed Swiss pilot study of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD submitted a paper describing the results to a peer-reviewed scientific journal. The paper is co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies. The study found clinically significant reductions in scores on the Clinician-Administered PTSD Scale (CAPS)—larger than those associated with Zoloft and Paxil, which are the currently approved medications for PTSD. The small number of subjects in this preliminary pilot study contributed to the results approaching but not reaching statistical significance. The investigators are now awaiting the reviewers' response to their submission.

Swiss Study: Final Report Submitted to SwissMedic

On October 14, 2011, MAPS' clinical research team submitted the final clinical study report for our recently completed Phase 2 Swiss study of MDMA-assisted psychotherapy for people with chronic, treatment-resistant PTSD to SwissMedic, the Swiss equivalent of the U.S. FDA. SwissMedic confirmed that the report had been received on October 18. The report, authored by MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., and MAPS Research and Information Specialist Ilsa Jerome, Ph.D., is required under International Council on Harmonization/Good Clinical Practice (ICH/GCP) and FDA regulations. The report contains information about the study protocol, information about the conduct of the study, and all study data in both raw and analyzed formats. The study team is now preparing the results for publication in a peer-reviewed academic journal.

A statistical analysis of the results reveals clinically significant decreases in scores on the Clinician-Administered PTSD Scale (CAPS), with an average reduction of 15.6 points. Due to the small number of subjects in this small pilot study, however, these decreases did not reach statistical significance. We did, however, observe trends toward statistical significance in both the CAPS and the Posttraumatic Diagnostic Scale (PDS), the two measures used to evaluate symptom severity in study subjects.

Swiss Study: Data Finalized for Swiss MDMA/PTSD Study

On June 1, 2011, MAPS' clinical research team completed their quality inspection of the database for our Swiss study of MDMA-assisted psychotherapy for PTSD. The database has been closed and locked (with a 0.04% error rate, far below the 0.5% required to pass), officially concluding the data collection phase of the study. With the final data set ready, the research team can now begin analyzing the data and assisting the investigator in preparing a manuscript to be published in a peer-reviewed scientific journal. The article will be co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies. The locked database will also be used for our final report to the US FDA.

Swiss Study: Team Begins Data Analysis

Now that we've completed our Swiss study of MDMA-assisted psychotherapy in 12 subjects with chronic, treatment-resistant PTSD, the clinical team is analyzing the data and assisting investigator Peter Oehen, M.D., in preparing a manuscript for publication. A preliminary analysis suggests that the Clinician-Administered PTSD Scale (CAPS), which is the primary measure of PTSD symptom severity, showed a trend towards improvement after treatment, with CAPS reductions somewhat larger than in comparable studies of Zoloft and Paxil. The Posttraumatic Diagnostic Scale (PDS), which is the secondary measure of PTSD symptoms completed by the subjects, also showed statistically significant improvements in symptoms after treatment.

The therapeutic results obtained in our previously completed U.S. flagship study of MDMA-assisted psychotherapy for PTSD were larger than those from our Swiss study. In order to determine how methodological, personnel, and/or cultural differences may have led to these differences, we are asking a series of questions about whether there were differences in (1) the population from which subjects were drawn, (2) the recruitment process, (3) the screening process, (4) the demographics of the subjects enrolled, (5) Swiss and American cultural approaches to PTSD, (6) the approaches of the various independent raters, and (7) the way in which subjects' PTSD symptoms were treated and/or evaluated by the clinicians. The answers to these questions will help MAPS understand how best to maximize therapeutic outcomes.

Swiss Study: Final Closeout Takes Place for Swiss MDMA/PTSD Study

From February 13-16, 2011, MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., visited Switzerland for the official closeout of our Swiss study of MDMA-assisted psychotherapy for PTSD with lead researcher Peter Oehen, M.D. This visit included cleaning up data, reviewing the investigator's files, collecting originals of essential documents and recordings, reviewing source records and case report forms, and preparing all materials for archiving. Some of the treatment session recordings from the Swiss study will also be used to compare and contrast the treatment methods of U.S. and Swiss therapists, since professional and cultural differences can lead to differences in approaches to treatment. One of MAPS' goals is to create a manualized treatment methodology that can be applied internationally, making comparisons especially important.

Swiss Study: Final Long-Term Follow-Up Visit Completed in Swiss MDMA/PTSD Pilot Study

On January 10, 2011, the final long-term follow-up visit was completed in MAPS’ Swiss study of MDMA-assisted psychotherapy for PTSD. The final subject (out of 12 total) was interviewed 12 months after the last treatment session, which took place on January 8, 2010. This is the final piece of data that will be collected for the study. The interviewers evaluated the subject to determine whether the effects of the treatment were maintained in the year following treatment, which involved evaluating the subject for symptoms of PTSD using the Clinician-Administered PTSD Scale (CAPS). The clinical team, led by Principal Investigator Peter Oehen, M.D., and co-therapist Verena Widmer, R.N., will now focus on writing a paper for publication and submitting the final report to SwissMedic. This study, which is part of MAPS’ clinical plan to develop MDMA into a prescription medicine approved by both US and European government regulatory agencies, is our first study using an active placebo dose of 25 mg MDMA. When the final report is completed, we will learn if the active placebo helped us to achieve an effective blind.

MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., will be joining the study team in Switzerland to assist with the study closeout, which will take place from February 13-16, 2011, after her work in Israel and Jordan.

Video Archiving Begins for Swiss MDMA/PTSD Study

Our Swiss MDMA/PTSD study collected video from nearly all of the sessions with treatment subjects. We are now preparing a method to archive the videos for future research purposes. This collection of video footage is a wealth of information about therapy techniques and subjects’ responses to MDMA-assisted psychotherapy. The archives will allow future researchers to do post-hoc analysis on the videos from a third-party perspective. These researchers may or may not be directly affiliated with MAPS. For example, this dataset could prove invaluable to Ph.D. dissertations or other scientific studies. We are currently investigating methods to duplicate and archive all this video data, which will be time-consuming and presumably costly. Should any researchers be interested in access to these videotapes, contact This email address is being protected from spambots. You need JavaScript enabled to view it.

Swiss MDMA/PTSD Data Being Processed

The experimental treatments in our Swiss MDMA/PTSD study were completed in January 2010. In January 2011, we will collect follow-up data from one remaining subject. The clinical research team is developing standardized data-entry conventions to aid analysis. Most of the data from the study already has been entered into a validated database. Clinical Research Associate Berra Yazar-Klosinski, Ph.D., will travel to Switzerland in February to collect the final data from Clinical Investigator Peter Oehen, M.D. While Berra is in Switzerland, she will close the study and archive the data the same way she archived the data this past month for our U.S. MDMA/PTSD study.

Switzerland Study: One-Year Follow-Up Study Proceeds

On January 8, 2010, the last of the experimental treatments were completed in the Swiss MDMA/PTSD study. The study, led by principal investigator Peter Oehen, M.D., with co-investigator Verena Widmer, R.N., treated 12 subjects with chronic, treatment-resistant PTSD. The investigators are currently collecting data for the one-year, long-term follow-up phase of the study. Eight subjects have already completed the long-term follow-up, three subjects have not yet done so, and sadly, one subject has died from an unrelated cause.

On June 14, 2010, at our office in Santa Cruz, CA, volunteer clinical research intern Tim Whalen finished building and validating the database for this study. On July 19, volunteer research intern Audrey Redfield, Ph.D. candidate (Institute of Transpersonal Psychology) finished entering the preliminary data into the database. Katharina Kirchner, M.A., who is assisting our Swiss end-of-life anxiety study, will also assist the investigators of this study with resolving data queries. The final analysis is scheduled for completion in January 2011, after the last measurements are collected from the final subject. We anticipate that the results will be submitted for publication in Spring 2011.

Swiss Study: One-Year Follow-Up Study Continues; Data Collection Underway

The experimental treatment portion of our Swiss study of MDMA-assisted psychotherapy for PTSD ended in January 2010. The long-term (one year) follow-up portion of the study is currently underway and will be concluded in January, 2011.

Our new volunteer research intern, Audrey Redfield, Ph.D. candidate (Institute of Transpersonal Psychology), is entering the completed data from the Swiss study into the clinical database at our office in Santa Cruz, CA. Audrey is now entering data from the ninth subject, out of 14 enrolled (12 completed and 2 drop-outs). In the interest of timeliness and accuracy, we will be checking the data as we go.

By the end of August 2010, we expect that this preliminary data entry will be completed. As the remaining subjects complete the long-term follow-up measures, we will be adding their data to the database. The final analysis will be completed shortly after the final subject participates in the long-term follow-up in January 2011. We are tentatively planning to complete the writing of a paper for publication in the spring of 2011.

Swiss Study: International Federation of Psychotherapy Congress in Lucern, Switzerland Hosts Mithoefers, Gasser, Oehen, and Passie

From June 16-19, the International Federation of Psychotherapy convened a Congress in Lucerne, Switzerland. As a sign of the growing acceptance of psychedelic psychotherapy research, this mainstream psychotherapy conference had a seminar devoted to the topic. From the U.S., MAPS sent researchers Michael Mithoefer M.D. and Annie Mithoefer, B.S.N. to present information from our U.S. MDMA/PTSD study. MAPS also brought Swiss MDMA/PTSD researchers Peter Oehen, M.D. and Verena Widmer, R.N. and Swiss LSD/end-of-life researcher Peter Gasser, M.D. Also on the panel was renowned German psychedelic researcher Torsten Passie, M.D. This was the first presentation about new data from psychedelic psychotherapy research to a mainstream psychotherapy conference in over 35 years.

Out of about 800 attendees at the conference, approximately 50 people crowded the room for the two-hour panel. According to MAPS Executive Director Rick Doblin, Ph.D. who also attended the conference, the session on psychedelic research was remarkable because it wasnt remarkable it was a mainstream psychotherapy conference that happened to have a panel on psychedelic psychotherapy research. There were no protestors or vocal dissenters. The promising results were taken seriously and our call for expanding research wasnt even considered controversial.

During the trip to Switzerland, MAPS supporter and friend Vanja Palmers hosted Rick and the Mithoefers at his home in Lucerne, only several blocks from the conference center.

Switzerland Study: One-Year Follow-Up Study Proceeds

The Swiss MDMA/PTSD study, led by Principal Investigator Peter Oehen M.D. with co-investigator Verena Widmer, R.N., has completed all experimental treatments and is currently in the one-year follow-up phase.The Swiss MDMA/PTSD study, led by Principal Investigator Peter Oehen M.D. with co-investigator Verena Widmer, R.N., has completed all experimental treatments and is currently in the one-year follow-up phase. The experiential portion of the study was completed in January 2010. Six subjects have completed the long-term follow-up, one subject has withdrawn from the long-term follow-up, and five subjects are yet to complete this portion of the study.

MAPS has built a new database to store the data for this study and the database has been verified for accuracy. We are now recruiting an intern or two to assist with data entry from this study. We will be choosing interns amongst applicants who pass stringent tests of accuracy in data entry. Katharina Kirchner, M.A. who is assisting our Swiss LSD/end-of-life anxiety study, will also be assisting the investigators of this study with data entry and data clean up. We anticipate that the data entry will take two months to complete, with additional time required to ensure accuracy of data in the database. The final analysis won’t be completed until the study ends at the beginning of 2011.

Switzerland Study: One-Year Follow-Up Study Proceeds

The Swiss MDMA/PTSD study, led by Principal Investigator Peter Oehen M.D. with co-investigator Verena Widmer, R.N., has completed all experimental treatments and is currently in the one-year follow-up phase. The experiential portion of the study was completed in January 2010. Six subjects have completed the long-term follow-up, one subject has withdrawn from the long-term follow-up, and five subjects are yet to complete this portion of the study.

MAPS has built a new database to store the data for this study and the database has been verified for accuracy. We are now recruiting an intern or two to assist with data entry from this study. We will be choosing interns amongst applicants who pass stringent tests of accuracy in data entry. Katharina Kirchner, M.A. who is assisting our Swiss LSD/end-of-life anxiety study, will also be assisting the investigators of this study with data entry and data clean up. We anticipate that the data entry will take two months to complete, with additional time required to ensure accuracy of data in the database. The final analysis won’t be completed until the study ends at the beginning of 2011.

Swiss Study: Monitoring Visit Conducted on Swiss MDMA and LSD Studies

In late February, MAPS Clinical Operations Manager Amy Emerson, Deputy Director Valerie Mojeiko, and MAPS new clinical research specialist Berra Yazar Ph.D., conducted a monitoring visit in Switzerland. They worked with Peter Oehen M.D. on the Swiss MDMA/PTSD study, which has completed treating all 12 patients, to help prepare the data for reporting to Swiss Medic and the FDA, and also for writing an article for submission to a scientific journal.

This same team also paid a monitoring visit to Peter Gasser M.D.s MAPS-sponsored Swiss LSD/end-of-life study. The monitoring visit revealed that its more difficult than we had originally anticipated to work with people who are close to dying, because their underlying disease process affects their health and their anxiety, as well as their ability to come to the psychotherapy sessions on a schedule.

Swiss LSD researcher Peter Gasser had a teleconference with Rick Doblin, Ph.D., MAPS Research and Information Specialist Ilsa Jerome, Ph.D., and MAPS Clinical Research Associate Berra Yazar, Ph.D. They discussed ways to align the windows during which certain procedures should be taking place with the diminished abilities to keep to a schedule of the actual patient population that they are working with.

Swiss Study: Active Treatment Phase Complete

Our Swiss MDMA/PTSD study has now completed active treatment of all 12 subjects and has obtained data from the two-month follow-up. The long-term follow-up (12 months post-treatment) is still underway, and will not be completed until January 2011.

The results were promising, approaching significance but only reaching the .1 level. The underlying reduction in PTSD symptoms was larger than the reductions obtained in the Zoloft and Paxil studies, which led to their approval by the FDA for the treatment of PTSD. If this study had been somewhat larger with more subjects, the results we obtained would become significant.

The leading researcher in this study, Peter Oehen, M.D., will be reporting on his results from this study at the upcoming Psychedelic Science in the 21st Century conference.

Swiss Study: Last MDMA Session in Switzerland

The final session in our Swiss MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) took place on Friday, January 8, 2010. The twelfth and final subject received MDMA in the stage two open label portion of the trial, which means that he had previously received a placebo dose. Two months from this last session will be the final data gathering point in this study. One year from now will be the final date point in the long-term follow of this research.

We are pleased to report that just like our U.S. pilot study there was an excellent safety record.  There is no evidence of any harm caused to any of the subjects by administering research grade MDMA in a therapeutic setting. Preliminary data analysis suggests that the research will have statistically significant results in reduction of PTSD symptoms in the subject population.

Dr. Peter Oehen's MAPS-sponsored study Update

Dr. Peter Oehen's MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic posttraumatic stress disorder (PTSD) has been making swift progress. Last Thursday, March 8, the second subject in Dr. Oehen's study underwent the second experimental treatment session. The third subject will undergo the first experimental session later this week, and the fourth and 5th subjects have already been recruited.

Swiss Study: Dr. Peter Oehen Conducts Second Experimental MDMA-Assisted Psychotherapy Session

Dr. Peter Oehen conducted the second experimental MDMA-assisted psychotherapy session with the second subject in his ongoing MAPS-sponsored MDMA-assisted therapy pilot study for subjects with treatment-resistant post-traumatic stress disorder (PTSD). According to Dr. Oehen, the subject delved into some challenging content, but the long-term results appear to be quite positive. "She was confronted very hard with anxiety, negative emotions related to the sexual abuse and especially her isolation and avoidance of closeness," said Dr. Oehen. "It was hard work for her in the following days but since then she has made substantial progress". Therapist reports confirm that the subject "confronted very hard with anxiety and with negative emotions related to their tramua - especially isolation and avoidance of closeness." This was followed by "hard work for the subject during the following days but since then they have made substantial progress."

Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD protocol

Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD protocol has full government approval and the first subject began the screening process last week. The Ethics Committee (the Swiss IRB equivalent, which previously approved Dr. Oehen's MDMA/PTSD protocol) met on September 7 to review an addendum to the protocol, and we just learned today, September 12, that the IRB has granted approval, meaning that the study can now officially be initiated! The addendum is for an associated study by Dr. Franz Vollenweider, University of Zurich, that will examine subjects before and after treatment with MDMA-assisted psychotherapy. Dr. Vollenweider is going to measure several physiological factors that have been associated with PTSD (startle response, heart rate reactivity) as well as various EEG parameters to see if the MDMA-assisted psychotherapy results in any changes in these measures. The first applicant for the study will be administered baseline CAPS and PDS tomorrow, and, now that we have full approval, we hope to report shortly that the first subject has been treated with MDMA-assisted psychotherapy.

Swiss Study: BAG Approves MDMA/PTSD Study

Switzerland's DEA equivalent, the BAG, has officially approved Dr. Peter Oehen's MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a treatment for subjects suffering from treatment-resistant Posttraumatic Stress Disorder (PTSD). Permission from BAG was the final regulatory hurdle, since Dr. Oehen has already received approval from the Ethics Committee (Switzerland's IRB equivalent) and SwissMedic (Switzerland's FDA equivalent).

Swiss Study: SwissMedic Approves MDMA/PTSD Study

Switzerland's FDA equivalent, SwissMedic, has now fully approved Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD study. The protocol design had already been approved, and earlier this week we received approval for the source of the MDMA itself, which MAPS is purchasing from a Swiss manufacturer. Now that Dr. Oehen has received permission from SwissMedic and an Ethics Committee (the Swiss IRB equivalent), the only regulatory hurdle remaining is licensing from BAG, the Swiss DEA equivalent, which is expected within a month. Initiation of Dr. Oehen's study will take place shortly thereafter.

Approval from SwissMedic of the source of the MDMA for the Swiss MDMA/PTSD study will now enable MAPS to move forward with the export of MDMA from Switzerland to Israel. The import/export of the MDMA is the last regulatory step in the initiation of Dr. Moshe Kotler's MAPS-sponsored MDMA/PTSD research at Beer Yaakov Mental Health Center in Tel Aviv, in subjects with war and terrorism-related PTSD.

Swiss Ethic Committee Approval for MDMA/PTSD Study

MAPS received word from Dr. Peter Oehen, Principal Investigator of the Swiss MDMA/PTSD pilot study cosponsored by MAPS and the Swiss Association for Psycholytic Therapy, that the final written approval from the ethic committee arrived today. Dr. Oehen will now submit the protocol and the other documents to Swissmedic, for a review process that we expect will take a month or two.

Swiss Study: Dr.Med. Peter Oehen Submits an MDMA/PTSD Protocol

Dr.med. Peter Oehen submits an MDMA/PTSD protocol for review to a Swiss ethics committee, for a pilot study co-sponsored by MAPS and the Swiss Association for Psycholytic Therapy (SAePT). This study will involve three experimental sessions instead of two and will use supplemental dosing 2 1/2 hours after the initial dose.