Lorrin Koran
Duloxetine for the Treatment of Dysthymia
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: duloxetine
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key 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
Additional Study Details
Official Title:
Duloxetine for the Treatment of DysthymiaAnticipated start date:
9/1/2004Lead Sponsor:
Stanford UniversityCollaborator(s):
- Eli Lilly and Company
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Inventory of Depressive Symptomatology (Clinician-Rated)
Secondary Outcomes:
- Clinical Global Impressions - Improvement
- Zung Self-Rating Depression Scale
- Patient Global Improvement
- Brief Pain Inventory
- WHO-QOL 100
Total Number to be Enrolled:
24Total Number to be Enrolled at Stanford:
24More Information
Publications About this Study:
- 17503986: Duloxetine treatment of dysthymia and double depression: an open-label trial.
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/25/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help