Medications for the Treatment of Dysthymic Disorder and Double Depression

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT00234312

Collaborator

Forest Laboratories (Industry)

Enrollment

Location

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2005

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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