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Trial record 32 of 47 for:    DESIPRAMINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265291
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : October 10, 2008
Information provided by:
National Institute of General Medical Sciences (NIGMS)

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 common and complex disorders in this population.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : November 1999
Actual Primary Completion Date : May 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: fluoxetine or desipramine
    fluoxetine 5-40 mg/day desipramine 50-150 mg/day
    Other Name: Prozac

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265291

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

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Julio Licinio, University of Miami Identifier: NCT00265291     History of Changes
Other Study ID Numbers: U01GM061394 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2005    Key Record Dates
Last Update Posted: October 10, 2008
Last Verified: September 2008
Keywords provided by National Institute of General Medical Sciences (NIGMS):
mood disorders
affective disorders
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors
Adrenergic Agents