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New Low Dose Depression Data Presented for Paxil CR (Paroxetine) Data Presented at the National Institute of Mental Health Meeting Also Show Favorable Tolerability and Low Patient Drop Out Rates CHAPEL HILL, NC -- June 13, 2002 -- Low dose (12.5mg/day) of controlled release paroxetine, known as Paxil CR™, was significantly superior to placebo in treating depression, according to data presented this week at the National Institute of Mental Health's (NIMH) annual National Clinical Drug Evaluation Unit (NCDEU) meeting. This study showed that controlled release paroxetine is well tolerated with low patient drop out rates. Additionally, in two separate pooled studies on controlled release paroxetine presented at the meeting subjects reported relief of depressed mood and anxiety symptoms after only one week of treatment and low rates of nausea, one of the most common side effects that cause people to stop taking antidepressant medication. "Often times, antidepressant treatment fails because patients find the side effects unacceptable, and if they refuse to take their medication they aren't going to have a good chance of getting better," said Robert N. Golden, M.D., lead investigator and professor and chair, Department of Psychiatry, University of North Carolina School of Medicine. "These data demonstrate that controlled release paroxetine has a favorable side effect profile without compromising the effectiveness of the medication." Controlled Release Paroxetine Shows Symptom Improvement as Early as Week One In two 12-week, randomized, double-blind, placebo-controlled, flexible dose (25mg-62.5mg) studies with 640 people diagnosed with major depression, controlled release paroxetine was found to be effective in improving depression and anxiety symptoms as early as the first week of treatment. Also during week one, patients taking controlled release paroxetine experienced low rates of nausea. "These data show that controlled release paroxetine is not only effective in treating depression, but its favorable tolerability profile may help patients adhere to treatment, in order to achieve full therapeutic benefit," said Dr. Golden. Study Shows Low Drop Out Rates An 8-week, randomized, double-blind, fixed-dose study of controlled release paroxetine and placebo found that low doses of controlled release paroxetine (12.5 mg/day and 25 mg/day) were significantly superior to placebo as measured by the Hamilton Rating Scale for Depression (HAM-D). In fact, fewer patients on 12.5 mg stopped treatment due to adverse events compared to placebo. In these studies, controlled release paroxetine was generally well tolerated. The most common adverse events (>10% and twice the rate of placebo) were abnormal ejaculation, constipation, diarrhea, dizziness, female genital disorder, and somnolence. About NCDEU The NCDEU Meeting is a scientific conference sponsored by the NIMH that brings together academic psychiatrists; psychologists; research pharmacists and nurses; investigators with the pharmaceutical industry; and representatives from NIMH and the Food and Drug Administration (FDA), who are interested in psychopharmacology and the broader areas of interventions and services research. About the University of North Carolina The University of North Carolina at Chapel Hill has been built by the people of the State and has existed for two centuries as the nation's first state university. Through its excellent undergraduate programs, it has provided higher education to ten generations of students, many of whom have become leaders of the state and the nation. Since the nineteenth century, it has offered distinguished graduate and professional programs. Funding for these studies was provided by GlaxoSmithKline. SOURCE: University of North Carolina School of Medicine E-mail this page to a friend or colleague! To print, use this version