Ethnic Variations in Antidepressant Response

Phase 4

Completed

• Conditions: Depression
• Interventions: Drug: Citalopram

• Registration Number: NCT00047671
• Lead Sponsor: National Institute of Mental Health (NIMH)

Brief Summary

This 11-week study aims to determine how genetic factors affect the way African Americans and Caucasians with major depression respond to antidepressant medication \[citalopram (Celexa®)\].

Detailed Description

Depressed patients vary substantially in their responses to antidepressants. Genetic factors may account for a large part of these differences in response. This study will include both African Americans and Caucasians to examine the role of genetic factors in treatment response.

Participants receive citalopram (Celexa) for 8 weeks and a placebo for 1 week. Visits occur once a week for 11 weeks. A variety of interviews, scales, tests, and questionnaires are used to assess participants.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-10-11
• Study First Submitted QC: 2002-10-15
• Study First Posted: 2002-10-16
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• DSM-IV criteria for Major Depression
• African-American or Caucasian ethnic background (both parents and 3 out of 4 grandparents)

Exclusion Criteria

• Schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression, or bipolar disorder
• Current drug abuse or history of drug abuse within the past 6 months
• Unstable medical or neurological conditions that interfere with the treatment of depression
• Allergy to citalopram
• Failure to respond to adequate citalopram drug trial (40 mg for at least 6 weeks)
• Seizure disorder
• Pregnancy
• Psychotropic medications, including antidepressants and neuroleptics
• Suicidal ideation or other safety issues
• Fluoxetine (Prozac) or MAOIs (Nardil, Parnate) in the last 2 months
• Ongoing cognitive behavioral therapy or intensive psychotherapy. General talk therapy is acceptable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Citalopram	Citalopram	All subjects receive an FDA approved dose of Citalopram

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression	Measured weekly for 11 weeks

Trial Locations

Locations (3)

Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit; 🇺🇸 Los Angeles, California, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

UCLA/King-Drew; 🇺🇸 Los Angeles, California, United States