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Medications for the Treatment of Dysthymic Disorder and Double Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00234312
First received: October 4, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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 Intervention Phase
Depression
Dysthymia
Drug: escitalopram and sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Escitalopram Vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

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

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

Estimated Enrollment: 40
Study Start Date: September 2005
Estimated Study Completion Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234312

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

No publications provided

ClinicalTrials.gov Identifier: NCT00234312     History of Changes
Other Study ID Numbers: 04-2801-A 02
Study First Received: October 4, 2005
Last Updated: September 7, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Depressive Disorders

Additional relevant MeSH terms:
Depression
Depressive Disorder
Dysthymic Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Sertraline
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014