Cannabidiol (CBD) is to be evaluated in the form of a trial for the treatment of post-traumatic stress disorder (PTSD). The lead organizations, ANANDA Scientific and NYU Grossman School of Medicine, announce that the first patient has enrolled in the clinical trial. Nantheia™ A1002N5S is the name of the drug that will be used as therapy in PTSD-affected participants.
Sohail R. Zaidi, President of ANANDA is delighted:
This is a significant milestone for ANANDA’s clinical development program, and we look forward to continuing our collaboration with NYU Grossman School of Medicine. We are impressed with the scientific rigor and professionalism of the NYU team in creating a program to test the efficacy of our very promising drug.
The initiation of patient enrollment for this study further reinforces our commitment to the goal of improving health and wellness based on cannabinoid research. This is also a significant step in our efforts to provide potentially improved treatment options for patients with PTSD.
Effect and correlations
Research Director Dr. Marmar (Director of NYU Langone PTSD Research Program) is involved in several individual medicine-based clinical trials. There, cutting-edge biomarker technology is being used with innovative therapies for PTSD and its typical comorbidities to understand the effect and correlations. Dr. Marmar is also excited about the collaboration with ANANDA Scientific and is full of confidence:
We are pleased that this important study is now underway. Thanks to our collaboration with ANANDA Scientific, we can proceed with the development of evidence-based CBD products for this distressing condition.
The study is an eight-week, randomized, placebo-controlled, double-blind, flexible-dose study. It is designed to test the effect of Nantheia™ A1002N5S on PTSD symptoms and neurocognitive function in 120 patients with PTSD. 50% of participants have comorbid mild traumatic brain injury (TBI).
The investigational drug NANTHEIA™ A1002N5S
Nantheia™ A1002N5S is an orally administered product containing 50 mg of cannabidiol (CBD) per softgel capsule. The investigational drug is used as a therapy for symptoms of post-traumatic stress disorder (PTSD) and neurocognitive impairment in patients with PTSD and PTSD comorbid with traumatic brain injury (TBI). In the drug, CBD is manufactured using ANANDA’s proprietary delivery technology. According to preclinical and also initial clinical studies, this technology can improve the effectiveness and stability of CBD.
What is post-traumatic stress disorder?
PTSD is a common disorder that can develop after a traumatic event. In the U.S., individuals exposed to military combat (at 12% to 20%) are significantly more likely to develop PTSD than those exposed to other events (1.3% to 12.2%). Symptoms include imprinting memories of the event, avoidance of recalling it, negative perceptions, and hyperexcitability. In addition, PTSD is associated with neurocognitive impairments. These lead to worsening of PTSD symptoms and affect treatment outcomes. Traumatic brain injury (TBI), experienced by up to 35% of veterans, is known to accompany PTSD. TBI also increases the risk of PTSD up to threefold. The course of TBI is an important factor in the development of treatment for PTSD: even mild TBI can result in long-term neurocognitive impairment as well as persistent post-traumatic symptoms. Current therapies do not reliably improve PTSD symptoms or associated neurocognitive impairments in PTSD or TBI. Therefore, novel and targeted medications are urgently needed.
This study should provide clarity and potentially provide improved treatment options for PTSD patients.