Apr. 8, 2005 STANFORD - Having trouble making decisions? Struggling with feelings of hopelessness? Suffering from low self-esteem?
Researchers at the Stanford University School of Medicine need volunteers who are suffering from these and other symptoms to test the safety and efficacy of a drug for the treatment of dysthymia, a low-grade and long-lasting type of depression.
Dysthymia is defined as chronic sad or depressed mood, accompanied by additional symptoms such as sleep disturbances, low self-esteem, difficulty concentrating or making decisions, low energy, feelings of hopelessness and/or weight or appetite change. It affects 3 to 6 percent of the adult population in the United States and differs from "regular depression" - what is commonly referred to as major depression - in having fewer symptoms present at one time (three to five vs. five to 12). Dysthymia sufferers are less likely to go to college, complete college and get a job consistent with their educational level, and the condition is associated with increased loss of work time as well as decreased life satisfaction.
Volunteers will be prescreened and, if eligible, will receive the drug duloxetine for 12 weeks. Eli Lilly & Co, the maker of duloxetine, is funding the study. While the Food and Drug Administration has approved this drug for the treatment of depression, it has not been approved for treatment of dysthymia. The drug acts to increase the availability of two chemical messengers in the brain, serotonin and norepinephrine, both of which are involved in the abnormal physiology that gives rise to depression and dysthymia.
"Since dysthymia usually starts before age 21, most people who have it think it's just 'part of my personality - I have always been that way,'" said Lorrin Koran, MD, professor of psychiatry and behavioral sciences. "In fact, it is not part of personality at all. It is just an illness that starts early in life and persists."
Koran, lead investigator on the study, said he believes treatment is important to relieve unnecessary suffering, to improve functioning in work and family roles, to allow normal enjoyment of life's rewards and to prevent the onset of major depression, with its great risk of total disability and suicidal behaviors.
This is an open-label study with no placebo, meaning that everyone in the study will receive the drug.
Participants are required to make 10 visits to the clinic over a period of 13 weeks, and participants will be interviewed at those times. Each visit should last about an hour, except for the initial screening visit, which will last approximately three hours and will include a physical examination and laboratory tests that involve providing a blood sample.
To be eligible for the study, subjects must be age 18 or older, and in relatively good health. They cannot be pregnant or breastfeeding, have problems with drugs or alcohol or have other major psychiatric diagnoses such as bipolar disorder.
To sign up or to obtain additional information, please contact the research study line at (650) 725-5180.
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