Status:
COMPLETED
Duloxetine for the Treatment of Dysthymia
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Dy...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- :
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00185575
Start Date
September 1 2004
End Date
April 1 2006
Last Update
April 9 2009
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305