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Medications for the Treatment of Dysthymic Disorder and Double Depression

Primary Purpose

Depression, Dysthymia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
escitalopram and sertraline
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depressive Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oregon Health Sciences University

Outcomes

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)

Full Information

First Posted
October 4, 2005
Last Updated
July 25, 2019
Sponsor
Oregon Health and Science University
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00234312
Brief Title
Medications for the Treatment of Dysthymic Disorder and Double Depression
Official Title
Escitalopram vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2005 (Actual)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Forest Laboratories

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Dysthymia
Keywords
Depressive Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
escitalopram and sertraline
Primary Outcome Measure Information:
Title
score on first 17 items of HAM-D Rating Scale 24 item, each visit
Secondary Outcome Measure Information:
Title
scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Boverman, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Medications for the Treatment of Dysthymic Disorder and Double Depression

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