If you think depression only affects the individual suffering from the disorder, or even their friends and family, think again. As a nation, depression affects all of us in one way or another. According to a report from the Journal of Clinical Psychology, a staggering amount of that impact is economic.
Depression (MDD) is the leading cause of disability for people aged 15-44, reports OptumHealth Reporting and Insights. Financially, that equates to billions of dollars spent on workplace costs, direct costs (which includes medical claims and pharmaceuticals) and suicide-related costs. Annual costs of MDD rose 21% to $210.5 billion in 2010, according to the Journal of Clinical Psychology, compared to costs in 2005.
Most experts agree that depression rates worldwide are on the rise. While there are nearly 50 variations of anti-depressants available in the U.S. alone, the often extensive trial and error process of finding a drug combination that reduces a patient’s depression symptoms is known to take months, even more than a year, and involves risks of serious side effects, including suicide. Studies show that fewer than 40% of depression sufferers benefit from first round treatments with current antidepressants, and the likelihood of achieving remission of depressive symptoms declines with each successive treatment attempt. Even more atrocious, as many as 15% of individuals suffering with MDD commit suicide.
There is an obvious, unarguable need for a breakthrough – a new generation of safe and faster-acting antidepressants.
One such candidate is ketamine, often used as an anesthetic but also popular as a dangerous street drug. The risk of potential abuse of ketamine, its intravenous administration, and its psychosis-like side effects somewhat crimp widespread acceptance in the medical field. And yet, ketamine’s rapid-acting effectiveness against treatment-resistant MDD is hard to ignore.
In San Francisco, a publicly traded, clinical-stage biopharmaceutical company is hard at work advancing its equally, if not more promising, solution – AV-101, an orally active NMDA receptor modulator.
Backed with funding by the U.S. National Institutes Health (NIH), VistaGen Therapeutics is collaborating with Dr. Carlos Zarate – a highly esteemed NIH clinician known for his deep experience with ketamine and other NMDA receptor antagonists – on a phase 2 clinical study of the efficacy and safety of AV-101 in subjects with MDD. As reflected by the NIH’s support, VistaGen’s AV-101 has the potential to deliver the rapid-acting antidepressant effects of ketamine, but without any of ketamine’s serious side effects.
Dr. Carlos Zarate is among the NIH’s leading clinical researchers on depression and other mood disorders, serving as the Chief of the Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the National Institutes of Mental Health (NIMH). He will be the principal investigator of the NIH-funded Phase 2 study of AV-101 in MDD. VistaGen and the NIH anticipate completing this important study in 2015.
In two prior NIH-funded randomized, double-blind, placebo-controlled phase 1 safety studies, AV-101 was well-tolerated and not associated with any severe adverse events. Nor were there any signs of sedation, hallucinations or schizophrenia-like side effects often associated with ketamine.
In addition to its candidacy as an effective MDD treatment, preclinical studies have also shown AV-101 as a potential as a treatment for other widespread CNS-related conditions, including chronic neuropathic pain and epilepsy, Parkinson’s and Huntington’s disease.
For more information, visit www.vistagen.com
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