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Ethnic Variations in Antidepressant Response

Ethnic Variations in Antidepressant Response

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00047671
Enrollment
400
Registered
2002-10-16
Start date
2002-06-30
Completion date
2006-11-30
Last updated
2009-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depressive Disorder

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.

Interventions

DRUGCitalopram

PDA Approved antidepressant

Sponsors

National Institute of Mental Health (NIMH)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hamilton Rating Scale for DepressionMeasured weekly for 11 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026