Status:
COMPLETED
Antidepressant Treatment of Mexican-Americans: UCLA Pharmacogenetics and Pharmacogenomics Research Group
Lead Sponsor:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Major Depressive Disorder
Major Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Our goal is to study pharmacogenetics in Mexican-Americans, using depression treatments as a proof of the concept that pharmacogenetic approaches can be used to optimize treatment strategies for commo...
Detailed Description
This is a single site, 8-week, double-blinded, placebo lead-in trial with fluoxetine or desipramine. All subjects have a comprehensive psychiatric and medical assessment, and if enrolled, continued wi...
Eligibility Criteria
Inclusion
- 1) At least 3 out of 4 grandparents born in Mexico \[12\]. 2) DSM-IV diagnosis of current, unipolar major depressive episode \[13\]. 3) 21-Item Hamilton Depression Rating Scale (HAM-D) \[14\] score of 18 or greater with item #1 (depressed mood) rated 2 or greater. 4) Age between 18-70 years.
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Exclusion
- 1) Any axis I disorder other than major depressive disorder (e.g. dementia, psychotic illness, bipolar disorder, adjustment disorder) or primary anxiety disorders. 2) Active medical illnesses that could be related to the ongoing depression (e.g. untreated hypothyroidism, recent myocardial infarction or cerebrovascular accident within the past six months, uncontrolled hypertension or diabetes). 3) Current suicidal ideation with a plan and strong intent, or recent serious suicide attempt. 4) Pregnant or lactating women, or women of childbearing age not using contraception. 5) History of electroconvulsive therapy in the last six months. 6) Current use of medications with central nervous system activity which interfere with EEG activity (e.g. benzodiazepines) or any other antidepressant treatment within the 2 weeks prior to enrollment. 7) History of poor response to therapeutic treatment with desipramine or fluoxetine. 8) Illicit drug use and/or alcohol abuse in the last three months. 9) Current enrollment in counseling or psychotherapies.
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Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00265291
Start Date
November 1 1999
End Date
October 1 2008
Last Update
October 10 2008
Active Locations (1)
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1
Center for Pharmacogenomics, University of Miami
Miami, Florida, United States, 33136