Antidepressant Treatment of Mexican-Americans: UCLA Pharmacogenetics and Pharmacogenomics Research Group
Information source: National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Major Depression; Unipolar Depression
Intervention: fluoxetine or desipramine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of General Medical Sciences (NIGMS) Official(s) and/or principal investigator(s): Julio Licinio, MD, Principal Investigator, Affiliation: University of Miami
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 common and complex disorders in this population.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: The Hamilton Depression Rating Scale (HAM-D) on a weekly basis
Secondary outcome: The Hamilton Anxiety Rating Scales (HAM-A), the Global Assessment Scale (GAS), the Beck Depression Inventory (BDI), and the Center for Epidemiological Depression Rating Scale (CES-D) on a weekly basis
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 with two consecutive phases of the study: 1) A one-week, single-blind
placebo lead-in phase to eliminate placebo responders. 2) Subsequent random assignment to
one of two treatment groups: fluoxetine 10-40 mg/day or desipramine 50-200 mg/day. Given the
proven efficacy of these antidepressant medications, a placebo lead-in period followed by
active treatment for all patients has been utilized in order to minimize human subjects at
risk.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: 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 Criteria: 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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Locations and Contacts
Center for Pharmacogenomics, University of Miami, Miami, Florida 33136, United States
Additional Information
Related publications: Flores DL, Alvarado I, Wong ML, Licinio J, Flockhart D. Clinical implications of genetic polymorphism of CYP2D6 in Mexican Americans. Ann Intern Med. 2004 Jun 1;140(11):W71.
Starting date: November 1999
Last updated: October 9, 2008
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