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

First Received on October 4, 2005. Last Updated on September 7, 2006 History of Changes

Sponsor:	Oregon Health and Science University
Collaborator:	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

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:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Sertraline hydrochloride Sertraline Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

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
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Sertraline
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012