Status:
COMPLETED
Medications for the Treatment of Dysthymic Disorder and Double Depression
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Forest Laboratories
Conditions:
Depression
Dysthymia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of flexible doses of escitalopram (Lexapro) compared to sertraline (Zoloft) for treatment of Dysthymic Disorder.
Detailed Description
Dysthymic Disorder is a common, chronic type of depression that is often seen as a mild condition and is under-treated. Because of its chronic course, it is often complicated by episodes of major depr...
Eligibility Criteria
Inclusion
- Primary diagnosis of Dysthymic Disorder or Major Depressive Disorder with Antecedent Dysthymia
- Women of childbearing potential must have negative pregnancy test at screen and agree to practice acceptable method of birth control
- Score of at least 12 on the 24-item Hamilton Depression Scale at study entry
- Initial screening labs grossly within normal limits
- Signed written informed consent
Exclusion
- Other Axis-I diagnoses such as delirium, dementia, and substance dependence (active in last year) or any substance abuse including alcohol within the past six months
- Actively suicidal
- CNS neoplasm, demyelinization disease, degenerative neurological disorder, active CNS infection, or any progressive CNS disorder that may confound interpretation of study results
- History of seizure disorder, or EEG showing paroxysmal activity or head CT showing gross structural abnormality
- Acute systemic medical disorder
- Use of any psychotropic medications within 2 weeks prior to screen or 4 weeks prior to screen in the case of fluoxetine
- Current use of any herbal medication such as St. John's wort,
- Uncontrolled renal, hepatic, endocrine, cardiovascular, pulmonary, immunological, hematological or gastrointestinal disease
- Any other abnormal medical screening tests judged by the investigator to be clinically significant
- Received any experimental medication within 30 days prior to study entry
- Patients presently in or soon to be starting psychotherapy
- Prior treatment non-response to an adequate trial of citalopram, escitalopram, or sertraline
- History of allergy to citalopram, escitalopram or sertraline
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00234312
Start Date
September 1 2005
End Date
October 1 2006
Last Update
July 29 2019
Active Locations (1)
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1
Oregon Health Sciences University
Portland, Oregon, United States, 97239