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Medications for the Treatment of Dysthymic Disorder and Double Depression

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Oregon Health and Science University
Forest Laboratories
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00234312
  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 IV

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Sertraline hydrochloride    Sertraline    Escitalopram    Benzetimide    Citalopram    Citalopram hydrobromide    Dexetimide    Escitalopram oxalate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Escitalopram Vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression

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

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


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

Keywords provided by Oregon Health and Science University:
Depressive Disorders  

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Sertraline
Dysthymic Disorder
Dexetimide
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 17, 2008




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