MYnd Analytics Receives IRB Approvals for SMART-MD Replication Trial
Approximately 500 Service Members, Veterans, and Family Members to Participate
MISSION VIEJO, Calif., April 01, 2016 (GLOBE NEWSWIRE) -- MYnd Analytics, Inc. (OTCQB:CNSO) obtained approval from two Institutional Review Boards to conduct a clinical trial of its Psychiatric EEG Evaluation Registry (PEER) Interactive platform, based on the protocol used at Walter Reed National Military Medical Center. The Company plans to enroll approximately 500 patients in the replication study with initial sites to include Canada and Southern California.
Using the largest psychiatric registry of patient outcomes in the world, the SMART-MD study will add to the four previous studies validating use of EEG to predict medication response. Like previous studies, the SMART-MD trial is expected to show the impact of PEER on reducing trial and error prescribing. Previous trials have shown that reduced trial and error prescribing improves Depression and PTSD, reduces suicidality, and improves treatment adherence.
PEER Interactive assists medical professionals in choosing the right medication for their patients utilizing a database of clinical outcomes and the results of a standard electroencephalogram (EEG). PEER provides doctors and their patients objective and patient-centered information about treatment options for mental health issues.
The randomized, double-blind, multi-site clinical study will enroll patients—including active duty military, veterans, and their families—with a primary diagnosis of Depression. The patients may also have comorbid disorders such as post-traumatic stress disorder (PTSD), mild traumatic brain injury (mTBI), and other mental health issues. Should the SMART-MD trial replicate previous results, the expected endpoint will be significant improvement in Depression, reduced Suicidal Ideation, and reduced PTSD symptoms among the experimental group.
The study is led by an experienced group of scientists and military leaders, including Colonel Rakesh Jetly, M.D., senior psychiatrist for the Canadian Armed Forces and Chair in Military Mental Health at the Canadian Military and Veterans Mental Health Centre of Excellence.
Colonel Jetly is joined by Vernor Knott, PhD, Director, Clinical Neuroelectrophysiology and Cognitive Research Laboratory, Institute of Mental Health Research, Ottawa, Ontario, one of the notable early researchers in studying the effects of medications on the human electroencephalogram. “I find PEER technology to be of great interest and, potentially, of great value in supporting more accurate prescribing of psychotropic agents.” said Knott. “I look forward to leading an important study of this technology in partnership with the Canadian armed forces and the commercial sponsor, MYnd Analytics.” Dr Knott will serve as principal investigator for the Canadian arm of the study.
Dan Iosifescu, M.D., Director of the Adult Psychopharmacology Program and Associate Professor of Psychiatry and Neuroscience at the Icahn School of Medicine at Mount Sinai in New York City, serves as lead investigator for the SMART-MD trial in the United States.
“It is vital that people suffering with mental health issues be able to get individualized care early in their treatment. This study offers the possibility of validating and refining a methodology that has shown promise in enhancing our ability to match patients with effective treatments,” said Dr. Iosifescu.
Colonel Jetly, M.D. concluded, “We have followed the research on this technology in the US and Canada, and are pleased that we can bring this trial to bear for our service members and veterans. We look forward to working with the MYnd Analytics team to further our understanding of outcomes using quantitative EEG tools such as PEER.”
About MYnd Analytics, Inc.
MYnd Analytics, Inc. (www.myndanalytics.com) provides a unique set of reference data and analytic tools for clinicians and researchers in psychiatry. While treatment for mental disorders has doubled in the last 20 years, it is estimated that 17 million Americans have failed two or more medication therapies for their mental disorders. The Company’s Psychiatric EEG Evaluation Registry, or PEER Online, is a new registry and reporting platform that allows medical professionals to exchange treatment outcome data for patients referenced to objective neurophysiology data obtained through a standard electroencephalogram (EEG). Based on the Company’s original physician-developed database, there are now more than 38,000 outcomes for over 10,000 unique patients in the PEER registry. The objective of PEER Online is to avoid trial and error pharmacotherapy, which is the dominant approach for treatment resistant patients. To read more about the benefits of this patented technology for patients, physicians and payers, please visit www.myndanalytics.com.
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Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements involve risks and uncertainties as set forth in the Company's filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.
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Released April 1, 2016