Clinical Trial: Ethnic Variations in Antidepressant Response

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine how genetic factors affect the way patients with major depression respond to antidepressant medication.

Condition Treatment or Intervention Phase
Depression
Depressive Disorder
 Drug: Citalopram
Phase IV

MedlinePlus related topics:  Depression;   Mental Health

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  400

Study start: June 2002;  Expected completion: December 2006

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.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

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

Location and Contact Information


California
      Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit, Los Angeles,  California,  90048,  United States; Recruiting
Sarah Rowe, BS  310-423-0744 
Russell E. Poland, PhD.,  Principal Investigator

      Harbor-UCLA Medical Center, Torrance,  California,  90502,  United States; Recruiting
Sandy Van  310-423-0744 

      UCLA/King-Drew, Los Angeles,  California,  90095,  United States; Recruiting
Mirianna Conde  323-563-4979 

More Information

Study ID Numbers:  EVA-00183-02
Record last reviewed:  January 2005
Last Updated:  January 31, 2005
Record first received:  October 11, 2002
ClinicalTrials.gov Identifier:  NCT00047671
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005