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Ethnic Variations in Antidepressant Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047671
Recruitment Status : Completed
First Posted : October 16, 2002
Last Update Posted : August 4, 2009
Information provided by:
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®)].

Condition or disease Intervention/treatment Phase
Depression Drug: Citalopram Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ethnic Variations in Antidepressant Response
Study Start Date : June 2002
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Active Comparator: Citalopram
All subjects receive an FDA approved dose of Citalopram
Drug: Citalopram
PDA Approved antidepressant

Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression [ Time Frame: Measured weekly for 11 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00047671

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United States, California
Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit
Los Angeles, California, United States, 90048
Los Angeles, California, United States, 90059
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lisa Glassman, Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit Identifier: NCT00047671    
Other Study ID Numbers: R01MH062531 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2002    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: August 2009
Keywords provided by National Institute of Mental Health (NIMH):
Depressive Disorder
Additional relevant MeSH terms:
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Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs