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Antidepressant Treatment of Mexican-Americans: UCLA Pharmacogenetics and Pharmacogenomics Research Group

This study has been completed.
Information provided by:
National Institute of General Medical Sciences (NIGMS) Identifier:
First received: December 13, 2005
Last updated: October 9, 2008
Last verified: September 2008
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.

Condition Intervention Phase
Major Depressive Disorder
Major Depression
Unipolar Depression
Drug: fluoxetine or desipramine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • The Hamilton Depression Rating Scale (HAM-D) on a weekly basis [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 8 weeks ]

Enrollment: 700
Study Start Date: November 1999
Study Completion Date: October 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluoxetine or desipramine
    fluoxetine 5-40 mg/day desipramine 50-150 mg/day
    Other Name: Prozac
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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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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Please refer to this study by its identifier: NCT00265291

United States, Florida
Center for Pharmacogenomics, University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Julio Licinio, MD University of Miami
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Julio Licinio, University of Miami Identifier: NCT00265291     History of Changes
Other Study ID Numbers: U01GM061394 ( US NIH Grant/Contract Award Number )
Study First Received: December 13, 2005
Last Updated: October 9, 2008

Keywords provided by National Institute of General Medical Sciences (NIGMS):
mood disorders
affective disorders

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on April 26, 2017