Ethnic Variations in Antidepressant Response

This study has been completed.
Information provided by:
National Institute of Mental Health (NIMH) Identifier:
First received: October 11, 2002
Last updated: August 3, 2009
Last verified: August 2009
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 Intervention Phase
Drug: Citalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ethnic Variations in Antidepressant Response

Resource links provided by NLM:

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: Measured weekly for 11 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2002
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Citalopram
All subjects receive an FDA approved dose of Citalopram
Drug: Citalopram
PDA Approved antidepressant

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00047671

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)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lisa Glassman, Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit Identifier: NCT00047671     History of Changes
Other Study ID Numbers: R01MH062531  EVA-00183-02  DATR A5-ETMA 
Study First Received: October 11, 2002
Last Updated: August 3, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Depressive Disorder

Additional relevant MeSH terms:
Antidepressive Agents
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors processed this record on May 23, 2016