A new medication to treat major depressive disorder in patients who have not responded to other antidepressants is being studied in a Phase II clinical trial by researchers at The University of Texas Health Science Center at Houston (UTHealth).
The drug, identified as BMS-820836 by its maker Bristol-Myers Squibb, affects the brain's neurotransmitters serotonin and norepinephrine, said the study's principal investigator Jair Soares, M.D., professor and chair of the Department of Psychiatry and Behavioral Sciences at the UTHealth Medical School.
"Serotonin, norepinephrine and dopamine are all important in the chemical imbalance in the brain that can lead to depression. Since not all patients respond to current medications, it's very important for us to study new drugs," said Soares, who is co-director of the UT Center of Excellence on Mood Disorders. "This is part of our commitment to innovation by offering patients access to cutting-edge research."
According to the World Health Organization, depression affects 121 million people around the world and is a leading cause of disability. From 20 to 30 percent of patients may not respond to the first antidepressant they take.
Enrollment for the international, multi-site, double-blinded study will last for two years. It is specifically for outpatients who have not responded to other antidepressants. All patients will begin the study by taking duloxetine (Cymbalta) and a placebo. After eight weeks, patients will remain on duloxetine but will also be randomized to either continue taking the placebo or add BMS-820836.
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