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

Major Depressive Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265291
• Other study ID #: U01GM061394
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2005
• Last updated: October 9, 2008
• Start date: November 1999
• Est. completion date: October 2008

Study information

• Verified date: September 2008
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 2008
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Major Depressive Disorder
• Unipolar Depression

Intervention

Drug:
• fluoxetine or desipramine
fluoxetine 5-40 mg/day desipramine 50-150 mg/day

Locations

Country	Name	City	State
United States	Center for Pharmacogenomics, University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Licinio J, O'Kirwan F, Irizarry K, Merriman B, Thakur S, Jepson R, Lake S, Tantisira KG, Weiss ST, Wong ML. Association of a corticotropin-releasing hormone receptor 1 haplotype and antidepressant treatment response in Mexican-Americans. Mol Psychiatry. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Hamilton Depression Rating Scale (HAM-D) on a weekly basis		8 weeks	No
Secondary	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		8 weeks	No