Results from Two New Pilot Studies Are Reported at the American Psychiatric Association Meeting in New Orleans
Thursday May 10
Source: PR Newswire
WEST CHESTER, Pa., May 10 /PRNewswire/ -- Data from two new pilot studies show that PROVIGIL(R) (modafinil) Tablets [C-IV] reduces fatigue and sleepiness in people who are clinically depressed and who are partial responders to antidepressant therapy.
Data from one study were presented on May 9 in a symposium at the annual meeting of the American Psychiatric Association (APA) in New Orleans. This study was a six-week pilot, double-blind, randomized study among 136 patients with major depressive disorder, who were partially responsive to their current antidepressant treatment. Study participants received between 100 mg and 400 mg of PROVIGIL daily. The most common side effects potentially attributable to PROVIGIL treatment included headache and nervousness.
Results of the study indicated that patients receiving PROVIGIL plus antidepressant treatment -- as compared to patients on antidepressant treatment plus placebo -- achieved statistically significant reductions (p<0.05) in fatigue, as measured by the Fatigue Severity Scale, and in sleepiness, as measured by the Epworth Sleepiness Scale.
Statistically significant improvements (p<0.05) in energy and concentration as measured by a sub-scale of the Hamilton Depression Scale (HAM-D retardation scale) were seen in patients taking PROVIGIL and various antidepressants including Prozac(R) (fluoxetine HCl), Zoloft(R) (sertraline HCl), or Paxil(R) (paroxetine HCl) but as anticipated, not in patients taking Celexa(TM), (citalopram HBr), a compound with which PROVIGIL has a known metabolic interaction. Results on the overall Hamilton Depression Scale (HAM-D 1-21), which contains elements that are not influenced by fatigue and cognitive function, did not distinguish PROVIGIL from placebo.
"Fatigue is a significant component of depression and a major problem in this patient population," reported Karl Doghramji, M.D., associate professor, department of psychiatry and human behavior at Jefferson Medical College of Thomas Jefferson University and Director, Sleep Disorders Center, Thomas Jefferson University Hospital, Philadelphia, one of the investigators in the multi-center study. "This study demonstrates that this medication may help the approximately 80 percent of patients that continue to experience fatigue and sleepiness associated with their depression."
This is the second pilot study to demonstrate the positive effects of PROVIGIL treatment on the symptom of fatigue. The first study in patients with Multiple Sclerosis related fatigue was presented last year at the American Academy of Neurology.
In a separate pilot study presented at a poster session at the APA meeting by Dr. Charles DeBattista of Stanford University, PROVIGIL was shown to significantly reduce fatigue in patients with depression. In the four-week, prospective, open-label study of 24 adults with major depressive disorder who were being treated with antidepressant therapy, patients treated with PROVIGIL demonstrated significant reductions in fatigue, as measured by the Fatigue Symptom Inventory and Fatigue Analog Scale. Improvements in cognition were also observed, particularly in concentration. Benefits were observed within two weeks of the start of therapy, and PROVIGIL was shown to be well tolerated in combination with a variety of antidepressants. The most reported side effect was headache.
Depression is a serious illness that affects more than 19 million American adults, according to the National Institutes of Mental Health. Fatigue is one of the most common complaints in depressed patients. Sleep complaints are also common, with approximately 20 percent of patients suffering from excessive sleepiness. These symptoms are often exacerbated by current treatments, since adverse events associated with many antidepressant therapies include hypersomnia and fatigue.
PROVIGIL is a novel, wake-promoting agent currently approved in several countries for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy. The most common side effects associated with PROVIGIL in treating EDS associated with narcolepsy include nausea, infection, nervousness, anxiety and insomnia.
Cephalon, Inc., (Nasdaq: CEPH) markets PROVIGIL in the United States, the United Kingdom, Ireland, and Italy and promotes the product in Austria and Switzerland under the brand name MODASOMIL(R). In addition, Cephalon holds exclusive marketing and distribution rights to PROVIGIL in Japan, South Korea, Taiwan and Latin America.
Cephalon, Inc., headquartered in West Chester, Pennsylvania, is an international biopharmaceutical company dedicated to the discovery, development and marketing of products to treat sleep and neurological disorders, cancer and pain.
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PROVIGIL is a registered trademark of Genelco, S.A., which is licensed to Cephalon, Inc.
Prozac is a registered trademark of Eli Lilly and Company
Zoloft is a registered trademark of Pfizer Inc.
Paxil is a registered trademark of GlaxoSmithKline
Celexa is a trademark of Forest Laboratories, Inc.
Contact: Sheryl Williams, 610-738-6493, or Mary Roche, 610-738-6415, both of Cephalon; or Jessica Masuga of GCI Healthcare, 212-537-8267