Medications for the Treatment of Dysthymic Disorder and Double Depression

NCT ID: NCT00234312

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-10-31

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.

Conditions

Depression; Dysthymia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

escitalopram and sertraline

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Joshua Boverman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Boverman, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health Sciences University

Portland, Oregon, United States

Countries

United States

Other Identifiers

04-2801-A 02

Identifier Type: -

Identifier Source: org_study_id