NCT00265291

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: National Institute of General Medical Sciences (NIGMS) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Major Depressive Disorder
• Major Depression
• Unipolar Depression

Interventions

Type	Name	Description
DRUG	fluoxetine or desipramine	fluoxetine 5-40 mg/day desipramine 50-150 mg/day

Timeline

• Start date: 1999-11-01
• Primary completion: 2006-05-01
• Completion: 2008-10-01
• First posted: 2005-12-14
• Last updated: 2008-10-10

Locations

1 site across 1 country: United States