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Study Suggests New Formulation of Paroxetine May Help Patients Adhere to Their Medication Compliance Common Problem at the Start of Antidepressant Therapy CHAPEL HILL, NC -- July 17, 2002 -- Controlled-release paroxetine, known as Paxil CR™, may increase treatment compliance for patients with depression, according to a study published in the July issue of the Journal of Clinical Psychiatry. This study demonstrated that controlled-release paroxetine is well tolerated with low patient dropout rates. Controlled-release paroxetine patients also reported low rates of nausea at week one, a common reason for stopping antidepressants early in the course of treatment. Research shows that more than half of patients taking antidepressants stop within the first three months because of adverse events. This is significant because expert guidelines recommend that patients take antidepressants for six months or longer to prevent relapse. "Patients stand a much greater chance of alleviating their depression if they complete a full course of antidepressant therapy," said Robert N. Golden, M.D., lead investigator and professor and chair, Department of Psychiatry, University of North Carolina School of Medicine. "Unfortunately, patients often stop prematurely because they can't tolerate the side effects associated with the medication. This study demonstrates that patients taking controlled-release paroxetine were able to tolerate the medication, with a low frequency of patient drop outs due to adverse events, which ultimately may help patients adhere to treatment." Study Finds Efficacy as Early as Week One of Treatment These study results include data pooled from two, 12-week, randomized, double-blind, placebo controlled, flexible-dose (25mg-62.5mg) studies of 640 patients diagnosed with depression. Results show that patients taking controlled-release paroxetine reported improvements in depressed mood and anxiety symptoms as early as the first week of treatment, as measured by the Hamilton Depression Rating Scale (HAM-D). Controlled-release paroxetine was well tolerated, with patients reporting low rates of nausea in the first week of treatment. "Given that treatment compliance is such a significant problem, doctors are always looking for ways to help patients stay on their medication," added Dr. Golden. "Having a medication with a low incidence of dropouts should help with this problem, making controlled-release paroxetine a valuable addition to the treatments available for depression." Supportive Data Also Presented at Recent NIMH Meeting Additionally, data recently released at the National Institute of Mental Health's annual National Clinical Drug Evaluation Unit (NCDEU) meeting showed that patients taking controlled-release paroxetine reported significantly greater life and medication satisfaction scores versus placebo as based on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The data in the study also showed that controlled-release paroxetine was significantly superior to placebo in treating depression, even in low doses (12.5 and 25mg/day). Most common adverse events (incidence of 5% or greater and incidence for Paxil CR at least twice that for placebo) in studies for major depressive disorder and panic disorder include infection, trauma, nausea, diarrhea, dry mouth, constipation, decreased appetite, somnolence, dizziness, decreased libido, tremor, yawning, sweating, abnormal vision, abnormal ejaculation, female genital disorders and impotence. Patients should not be abruptly discontinued from antidepressant medication, including Paxil CR. Concomitant use of Paxil CR in patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated. 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. SOURCE: University of North Carolina E-mail this page to a friend or colleague! To print, use this version