DepressionPhase 4NCT00047671
Ethnic Variations in Antidepressant Response
A Phase 4 study testing Citalopram in people with Depression, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
Trial 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®)]. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Citalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2002to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV criteria for Major Depression
- African-American or Caucasian ethnic background (both parents and 3 out of 4 grandparents)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cedars-Sinai Medical Center, Department of Psychiatry, Clinical Trials Unit
Los Angeles, California, 90048
UCLA/King-Drew
Los Angeles, California, 90059
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
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®)].
Read the 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.
- Conditions
- Depression
- Being tested
- Citalopram
- Keywords
- Depressive Disorder
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
PDA Approved antidepressant
| Study group | Role | What they receive |
|---|---|---|
| Citalopram | Active comparator | All subjects receive an FDA approved dose of Citalopram Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Measured: Measured weekly for 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2002 (estimated)
- Study startJun 2002
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047671
- Sponsor's protocol ID
- R01MH062531
- Other IDs
- EVA-00183-02, DATR A5-ETMA
- Status last verified
- Aug 2009
- First submitted
- 11 Oct 2002
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23562852Joseph 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.
PubMed 21916630
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic Variations in Antidepressant Response
- ClinicalTrials.gov ID
- NCT00047671
- Acronym / sponsor ID
- R01MH062531
- Conditions
- Depression
- Keywords
- Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 16 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Citalopram | Active comparator | Drug: CitalopramAll subjects receive an FDA approved dose of Citalopram |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM-IV criteria for Major Depression
- African-American or Caucasian ethnic background (both parents and 3 out of 4 grandparents)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramPDA Approved antidepressant | Drug | Citalopram |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: Measured weekly for 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
- Derived from this study: PubMed 23562852Poland 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.
- Derived from this study: PubMed 21916630Joseph 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Citalopram in people with Depression, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (time frame: Measured weekly for 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00047671, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2009.