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

This study has been completed.
Sponsor:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00265291
First received: December 13, 2005
Last updated: October 9, 2008
Last verified: September 2008
History of Changes
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265291

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Julio Licinio, University of Miami
ClinicalTrials.gov Identifier: NCT00265291     History of Changes
Other Study ID Numbers: U01GM061394
Study First Received: December 13, 2005
Last Updated: October 9, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Desipramine
Fluoxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on June 18, 2013