Lykos Therapeutics announced today that the FDA has not approved their application for an MDMA based drug with psychotherapy to treat PTSD because of concerns about how the pharmaceutical company conducted its trials. Lykos Therapeutics was also cited for unethical conduct at one of its research locations after one of its therapists had been accused of practicing without a license and of sexually assaulting one of the participants in Lykos’ MDMA trials.

     MDMA – more commonly known as Ecstasy or Molly — is an illicit, mind-altering psychedelic drug that can affect a user’s visual and time perceptions. While usually taken recreationally to chemically increase happiness and energy levels, MDMA can cause potentially severe “side effects” such as high blood pressure, vomiting, heart problems or liver damage, per the National Institute of Health.

     MDMA is classified as a Schedule I drug under the Controlled Substances Act and it has “no currently accepted medical use,” but it does have “a high potential for abuse.”

     Despite that, and apparently prompted by anecdotal “evidence” that taking MDMA may for a few lead to a positive mental shift away from depression and anxiety, psychiatrists and pharmaceutical companies are now trying to get FDA approval for its use those who have not had relief from taking standard antidepressants.

     Such is the interest of this psychedelic avenue of approach that a $3 million professorship was established at Yale University last fall by Vikram Sodhi to study the value of DMT – an illicit derivative drug of the South American shaman potion ayahuasca — to psychiatric treatments for PTSD. Deepak Cyril D’Souza was named the inaugural Vikram Sodhi Professor of Psychiatry at Yale.

     “We don’t, as yet, know how long a person needs to have psychedelic effects in order to be able to derive antidepressant effects,” D’Souza said. “Another question is how intense a psychedelic experience do you need order to be able to derive antidepressant effects?”

     His questions seem a grim reminder of the MKUltra experiments with psychoactive drugs such as LSD which were carried out by the CIA in the nineteen-fifties to identify drugs that could be used during interrogations.

Science Insider has reported that today at least two other pharmaceutical companies are also involved in clinical trials to evaluate the use of psilocybin – known on the street as magic mushrooms – to treat depression.

     Despite the early momentum seen for these experimental trials, the Institute for Clinical and  Economic Review reported this year that insufficient evidence has been found for any benefits from the research which would outweigh the known risks of cardiovascular problems, worsening mental health problems, and suicidal thoughts that come from these drugs.