Post Traumatic Stress Disorder Phase II Clinical Trial

University of Nebraska Medical Center
Omaha, Nebraska

In collaboration with the University of Nebraska Medical Center (UNMC), ANANDA Scientific has embarked on a second groundbreaking clinical trial to address the pressing issue of post-traumatic stress disorder (PTSD) in adults. The primary investigator for this trial is Mathew Rizzo, MD, FAAN,FANA and it will evaluate Nantheia™ ATL5, Ananda’s second investigational CBD drug utilizing its proprietary Liquid Structure ™ delivery technology for the treatment of PTSD. With the NYU PTSD study evaluating Nantheia™ A1002N5S, Ananda’s other investigational CBD drug, this trial will give us the opportunity to compare the two different investigational drugs in this important indication.


This comprehensive phase II, double-blind, placebo-controlled trial will focus both on the efficacy of Nantheia™ ATL5 in treating PTSD, as well as safety. It will also access the multifaceted dimensions of PTSD symptomatology and offer a holistic approach to an individual’s well-being and daily life. The diverse clinical trial team at UNMC comprises experts spanning neuroscience, psychiatry, neuroimaging, and public policy, and we anticipate this clinical trial will contribute significantly to our understanding of CBD’s role in mitigating the effects of PTSD.


The primary endpoint will be measured by the CAPS-5R score (an updated validated measure of person’s PTSD symptoms) change from baseline while the secondary endpoints measured by a comprehensive assessment of safety, tolerability, and the broader impact on patients’ lives.


For more details, refer to the clinicaltrials.gov link (https://clinicaltrials.gov/study/NCT05269459) and press releases issued over the course of the study:


1. University of Nebraska Medical Center and ANANDA Scientific announce First Patient Enrolled in FDA- approved clinical trial for Post-Traumatic Stress Disorder (PTSD) https://www.businesswire.com/news/home/20230314005182/en/University-of-Nebraska-Medical-Center-a nd-ANANDA-Scientific-announce-First-Patient-Enrolled-in-FDA-approved-clinical-trial-for-Post-Traumatic-St ress-Disorder-PTSD


2. University of Nebraska Medical Center and ANANDA Scientific announce FDA approval of the IND for a Clinical Trial exploring Treatment for Post-Traumatic Stress Disorder (PTSD http://www.businesswire.com/news/home/20220517005065/en