Clinical trial NCT00047671: Ethnic Variations in Antidepressant Response
Official title: Ethnic Variations in Antidepressant Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Depressive Disorder
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 2002-10-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[citalopram (Celexa®)\].

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 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: Measured weekly for 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit
state: California
city: Los Angeles
country: United States
facility: UCLA/King-Drew
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
References:
citation: 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.
citation: Joseph 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.