Medications for the Treatment of Dysthymic Disorder and Double Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00234312
• Date of registration: 04/10/2005
• Primary sponsor: Oregon Health and Science University
• Public title: Medications for the Treatment of Dysthymic Disorder and Double Depression
• Scientific title: Escitalopram Vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression
• Date of first enrolment: September 2005
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00234312
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Joshua Boverman, MD
• Affiliation: Oregon Health and Science University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Dysthymia

Intervention(s)

Drug: escitalopram and sertraline

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

04-2801-A 02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories