Ethnic Variations in Antidepressant Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2006-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Citalopram

All subjects receive an FDA approved dose of Citalopram

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

PDA Approved antidepressant

Interventions

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Citalopram

PDA Approved antidepressant

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No