Medications for the Treatment of Dysthymic Disorder and Double Depression

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Forest Laboratories
• Treatments: Citalopram; Dexetimide; Sertraline

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