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Medications for the Treatment of Dysthymic Disorder and Double Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234312
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : July 29, 2019
Forest Laboratories
Information provided by (Responsible Party):
Joshua Boverman, MD, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Depression Dysthymia Drug: escitalopram and sertraline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Escitalopram vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression
Actual Study Start Date : September 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Primary Outcome Measures :
  1. score on first 17 items of HAM-D Rating Scale 24 item, each visit

Secondary Outcome Measures :
  1. scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234312

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United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Forest Laboratories
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Principal Investigator: Joshua Boverman, MD Oregon Health and Science University

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Responsible Party: Joshua Boverman, MD, Principal Investigator, Oregon Health and Science University Identifier: NCT00234312     History of Changes
Other Study ID Numbers: 04-2801-A 02
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Keywords provided by Joshua Boverman, MD, Oregon Health and Science University:
Depressive Disorders
Additional relevant MeSH terms:
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Depressive Disorder
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents