Duloxetine for the Treatment of Dysthymia
1 other identifier
interventional
24
1 country
1
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. Dysthymia is chronic, mild depression characterized by feeling sad or low more days than not for more than 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedApril 9, 2009
April 1, 2009
1.6 years
September 9, 2005
April 7, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Inventory of Depressive Symptomatology (Clinician-Rated)
Secondary Outcomes (5)
Clinical Global Impressions - Improvement
Zung Self-Rating Depression Scale
Patient Global Improvement
Brief Pain Inventory
WHO-QOL 100
Interventions
Eligibility Criteria
You may qualify if:
- Sign an informed consent form
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Eli Lilly and Companycollaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (1)
Koran LM, Aboujaoude EN, Gamel NN. Duloxetine treatment of dysthymia and double depression: an open-label trial. J Clin Psychiatry. 2007 May;68(5):761-5. doi: 10.4088/jcp.v68n0514.
PMID: 17503986RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorrin M Koran
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
September 1, 2004
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
April 9, 2009
Record last verified: 2009-04