NCT00047671

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Jun 2002

Typical duration for phase_4 depression

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2002

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

4.4 years

First QC Date

October 11, 2002

Last Update Submit

August 3, 2009

Conditions

Keywords

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression

    Measured weekly for 11 weeks

Study Arms (1)

Citalopram

ACTIVE COMPARATOR

All subjects receive an FDA approved dose of Citalopram

Drug: Citalopram

Interventions

PDA Approved antidepressant

Citalopram

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

UCLA/King-Drew

Los Angeles, California, 90059, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

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.

  • 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.

MeSH Terms

Conditions

DepressionDepressive Disorder

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

Locations