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Duloxetine for your management of dysthymia - full text view - clinicaltrials.gov

The purpose of this research would be to obtain information on the protection and effectiveness of duloxetine (Cymbalta) inside the treatments for dysthymia. Duloxetine has been approved by the federal Food and Drug Administration to the management of depression. The use of duloxetine to treat dysthymia is known as experimental.

Dysthymia is defined as chronic, low-grade depression, seen as a feeling low or depressed, that takes two or more years. Additional symptoms can include: poor appetite or overeating; insomnia or sleeping too much; low energy or fatigue; low self-esteem; poor concentration or difficulty making decisions; and feelings of hopelessness.

Dysthymia affects 3-6% from the general population, but can be an underdiagnosed and undertreated disorder. In double-blind, placebo-controlled many studies of antidepressant medications, dysthymia response rates are around 60%, when compared with a typical placebo response rate of about 30%. Duloxetine hasn't been studied inside therapy for dysthymia, but indicates brings about treating major depression. Inside a 9-week, double-blind, placebo-controlled study of 257 patients with depressive disorder, 65% responded duloxetine 60mg/day, when compared with 43% to placebo. Based on these results, it can be highly likely that duloxetine will likely be just right for dysthymia.

This research study is being conducted at Stanford University Medical Center using a total of 24 patients, age 18 and above, with dysthymia.

In the study, subjects will receive duloxetine for 12 weeks. This is surely an open-label study, meaning that every subject receives the research medication.

In total, subjects emerged for 10 visits across 13 weeks. At each visit subjects' pulse rate, blood pressure levels and weight measurements are going to be obtained. At each visit study personnel will interview subjects relating to symptoms, monitor unwanted effects and inquire these to complete study questionnaires.

Beginning in the second visit, subjects receive duloxetine 60 mg/day. If they experience negative effects, the dose can be decreased to 30 mg/day for a few days, and definitely will be increased to 60 mg/day at the end in the first week. If subjects can't tolerate a dose of 60 mg/day as a result of negative effects, they'll be withdrawn from your study. At the tip of About six weeks, whether they have not answered the investigation medication (as dependant on doctor ratings according to subjects' reports), the dose of duloxetine is going to be increased to 120 mg/day, unless subjects are experiencing troubling uncomfortable side effects. Subjects continue on the minimum dose thats liable to bring about remission or even the maximum tolerated dose to the remaining About 6 weeks. Medication dosing will probably be flexible and based on tolerance (unwanted side effects) and therapeutic effect buy macrobid online without a prescription.