Medications for the Treatment of Dysthymic Disorder and Double Depression

Completed · Phase 4

Conditions studied: Depression, Dysthymia

In brief

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.

Key facts

Study ID

NCT00234312

Run by

Oregon Health and Science University

People needed

40

Starts

2005-09-01

Expected to finish

2006-10-01

Last updated by the study team

2019-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oregon Health Sciences University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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