Ethnic Variations in Antidepressant Response
3 other identifiers
interventional
400
1 country
3
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 \[citalopram (Celexa®)\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 depression
Started Jun 2002
Typical duration for phase_4 depression
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 11, 2002
CompletedFirst Posted
Study publicly available on registry
October 16, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedAugust 4, 2009
August 1, 2009
4.4 years
October 11, 2002
August 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Rating Scale for Depression
Measured weekly for 11 weeks
Study Arms (1)
Citalopram
ACTIVE COMPARATORAll subjects receive an FDA approved dose of Citalopram
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV criteria for Major Depression
- African-American or Caucasian ethnic background (both parents and 3 out of 4 grandparents)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit
Los Angeles, California, 90048, United States
UCLA/King-Drew
Los Angeles, California, 90059, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Related Publications (2)
Poland RE, Lesser IM, Wan YJ, Gertsik L, Yao J, Raffel LJ, Lin KM, Myers HF. Response to citalopram is not associated with SLC6A4 genotype in African-Americans and Caucasians with major depression. Life Sci. 2013 May 30;92(20-21):967-70. doi: 10.1016/j.lfs.2013.03.009. Epub 2013 Apr 3.
PMID: 23562852DERIVEDJoseph NT, Myers HF, Schettino JR, Olmos NT, Bingham-Mira C, Lesser IM, Poland RE. Support and undermining in interpersonal relationships are associated with symptom improvement in a trial of antidepressant medication. Psychiatry. 2011 Fall;74(3):240-54. doi: 10.1521/psyc.2011.74.3.240.
PMID: 21916630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 11, 2002
First Posted
October 16, 2002
Study Start
June 1, 2002
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
August 4, 2009
Record last verified: 2009-08