- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00234312
Medications for the Treatment of Dysthymic Disorder and Double Depression
Escitalopram vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression
Study Overview
Status
Conditions
Intervention / Treatment
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 depression and may require long-term treatment.
This is a twelve week study during which daily doses of escitalopram (10-20 mg) or sertraline (50-200 mg) will be given to outpatients meeting criteria for Dysthymic Disorder or Double Depression. Medications will be assigned 1:1 and clinicians will be blinded to treatment. Efficacy will be based on scores for the Hamilton Depression Rating Scale, patient subjective reporting, and clinician observation. The study will have a total of 8 visits over 12 weeks, with a one-week medication taper period at the end. Subjects will have a physical exam, labs, and vital signs monitored at first visit and vital signs monitored at every subsequent visit. Women of childbearing potential must have a negative urine pregnancy test at screening. All subjects will remain on the lowest medication dose for the first four weeks of the study.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health Sciences University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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score on first 17 items of HAM-D Rating Scale 24 item, each visit
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Secondary Outcome Measures
Outcome Measure |
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scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joshua Boverman, MD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Dysthymic Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Sertraline
- Citalopram
Other Study ID Numbers
- 04-2801-A 02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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