Overview
Duloxetine for the Treatment of Dysthymia
Status:
Completed
Completed
Trial end date:
2006-04-01
2006-04-01
Target enrollment:
0
0
Participant gender:
All
All
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. Dysthymia is chronic, mild depression characterized by feeling sad or low more days than not for more than 2 years.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Stanford UniversityCollaborator:
Eli Lilly and CompanyTreatments:
Duloxetine Hydrochloride
Criteria
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