Medications for the Treatment of Dysthymic Disorder and Double Depression

NCT00234312 | Completed Phase 4

• 1 other identifier: 04-2801-A 02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Dysthymia

Keywords

Depressive Disorders

Outcome Measures

Primary Outcomes (1)

• score on first 17 items of HAM-D Rating Scale 24 item, each visit

Secondary Outcomes (1)

• scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)

Interventions

escitalopram and sertraline DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Depression; Dysthymic Disorder; Depressive Disorder

Interventions

Escitalopram; Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Joshua Boverman, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 6, 2005
• Study Start: September 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: July 29, 2019

Record last verified: 2019-07

Locations

US (1)