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Ethnic Variations in Antidepressant Response

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 4

Conditions

Depression

Treatments

Drug: Citalopram

Study type

Interventional

Funder types

NIH

Identifiers

NCT00047671
R01MH062531
DATR A5-ETMA
EVA-00183-02

Details and patient eligibility

About

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®)].

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 1 patient group

Citalopram
Active Comparator group
Description:
All subjects receive an FDA approved dose of Citalopram
Treatment:
Drug: Citalopram

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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