09 Jun FDA approves MDMA for clinical trial use investigating schizophrenia

By Alana Hippensteele, Pharmacy Times

The FDA has approved a clinical trial investigating an ± 3,4-methylenedioxymethamphetamine (MDMA) investigational medical product (IMP; LaNeo MDMA, PharmAla) in 40 mg capsules. The trial (NCT05770375) will be conducted at the University of California, Los Angeles and will examine the use of this drug to assess its tolerability in patients with schizophrenia.

Specifically, the investigators will be assessing the use of the drug to treat impaired social motivation, or asociality, which is a symptom of schizophrenia that can cause significant functional impairment. Although schizophrenia symptoms can be treated with antipsychotics, there is currently no effective treatment for asociality.

MDMA is known to have pronounced pro-social effects, which can increase the motivation for individuals to engage socially. In prior research conducted among healthy volunteers, MDMA was shown to produce feelings of empathy and closeness with others, as well as increase attention paid to positive social cues. The study investigators hypothesize that this increased level of empathy and perceived closeness may partly be due to MDMA’s effects on the social bonding hormone oxytocin. Read more …