Medications for the Treatment of Dysthymic Disorder and Double Depression
This trial is active, not recruiting.
|Treatment||escitalopram and sertraline|
|Sponsor||Oregon Health and Science University|
|Start date||September 2005|
|End date||October 2006|
|Trial size||40 participants|
|Trial identifier||NCT00234312, 04-2801-A 02|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
score on first 17 items of HAM-D Rating Scale 24 item, each visit
scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)
Male or female participants at least 18 years old.
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
|Official title||Escitalopram Vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression|
|Principal investigator||Joshua Boverman, MD|
|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.|
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