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| Sponsor: | National Institute of General Medical Sciences (NIGMS) |
|---|---|
| Information provided by: | National Institute of General Medical Sciences (NIGMS) |
| ClinicalTrials.gov Identifier: | NCT00265291 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
| 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) |
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 |
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
More Information
| Responsible Party: | University of Miami ( Julio Licinio ) |
| Study ID Numbers: | U01GM061394 |
| Study First Received: | December 13, 2005 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00265291 History of Changes |
| Health Authority: | United States: Federal Government |
|
Depression mood disorders affective disorders pharmacogenetics pharmacogenomics |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Desipramine Pathologic Processes Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation |
Antidepressive Agents Disease Depression Enzyme Inhibitors Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Antidepressive Agents, Tricyclic Fluoxetine Serotonin Agents Mood Disorders Central Nervous System Agents |