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Ethnic Variations in Antidepressant Response

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047671
First Posted: October 16, 2002
Last Update Posted: August 4, 2009
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.
Information provided by:
National Institute of Mental Health (NIMH)
  Purpose
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
Depression Drug: Citalopram Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00047671


Locations
United States, California
Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit
Los Angeles, California, United States, 90048
UCLA/King-Drew
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Glassman, Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit
ClinicalTrials.gov Identifier: NCT00047671     History of Changes
Other Study ID Numbers: R01MH062531 ( U.S. NIH Grant/Contract )
EVA-00183-02
DATR A5-ETMA
First Submitted: October 11, 2002
First Posted: October 16, 2002
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:
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents