Duloxetine for the Treatment of Dysthymia
Duloxetine for the Treatment of Dysthymia
The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of
 60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients suffering
 from dysthymia. Dysthymia is chronic, mild depression characterized by feeling sad or low
 more days than not for more than 2 years.
The purpose of this research is to obtain information on the safety and effectiveness of
 duloxetine (Cymbalta) in the treatment of dysthymia. Duloxetine has been approved by the
 federal Food and Drug Administration for the treatment of depression. The use of duloxetine
 for treatment of dysthymia is considered experimental.

 Dysthymia is defined as chronic, low-grade depression, characterized by feeling low or
 depressed, that lasts for two or more years. Additional symptoms may 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% of the general population, but is an underdiagnosed and undertreated
 disorder. In double-blind, placebo-controlled clinical trials of antidepressant medications,
 dysthymia response rates are around 60%, compared to an average placebo response rate of
 about 30%. Duloxetine has not been studied in the treatment of dysthymia, but has shown
 results in the treatment of major depression. In a 9-week, double-blind, placebo-controlled
 study of 257 patients with major depression, 65% responded to duloxetine 60mg/day, compared
 to 43% to placebo. Based on these results, it is highly likely that duloxetine will be an
 effective treatment for dysthymia.

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

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

 In total, subjects are seen for 10 visits across 13 weeks. At each visit subjects' heart
 rate, blood pressure and weight measurements will be obtained. At each visit study personnel
 will interview subjects about their symptoms, monitor side effects and ask them to complete
 study questionnaires.

 Beginning at the second visit, subjects receive duloxetine 60 mg/day. If they experience side
 effects, the dose can be decreased to 30 mg/day for several days, but will be increased back
 to 60 mg/day by the end of the first week. If subjects are unable to tolerate a dose of 60
 mg/day due to side effects, they will be withdrawn from the study. At the end of 6 weeks, if
 they have not responded to the study medication (as determined by doctor ratings based on
 subjects' reports), the dose of duloxetine will be increased to 120 mg/day, unless subjects
 are experiencing troubling side effects. Subjects continue on the minimum dose that brings
 about remission or the maximum tolerated dose for the remaining 6 weeks. Medication dosing
 will be flexible and determined by tolerance (side effects) and therapeutic effect.
Inclusion Criteria::

 -  Sign an informed consent form

 -  18 years of age or older

 -  Females not pregnant or breastfeeding or planning pregnancy and using an acceptable
 form of contraception

 -  Meet DSM-IV criteria for dysthymia

 -  A screening IDS-C score of 17 or greater

 -  No history of serious or unstable medical disorder

 -  Not taking any significant concurrent medications

 -  Not currently receiving psychotherapy Exclusion Criteria:- Suffering from DSM-IV
 defined

 -  delirium, dementia, amnestic, or other cognitive disorders

 -  mental disorders due to a general medical condition

 -  factitious or somatoform disorders

 -  mental retardation or developmental disabilities

 -  substance or alcohol abuse within the last 3 months

 -  depressive disorders with current suicidal risk

 -  psychotic disorders including delusional disorder, somatic type

 -  dissociative disorder

 -  personality disorders sufficiently severe to interfere with study participation

 -  History of DSM-IV defined bipolar I or II disorder

 -  History of non-response of dysthymia to adequate antidepressant medication

 -  History of major depression refractory to two adequate trials of antidepressants