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Antidepressant Treatment of Mexican-Americans: UCLA Pharmacogenetics and Pharmacogenomics Research Group

NCT ID: NCT00265291

Last Updated: 2008-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Study Completion Date

2008-10-31

Brief Summary

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Our goal is to study pharmacogenetics in Mexican-Americans, using depression treatments as a proof of the concept that pharmacogenetic approaches can be used to optimize treatment strategies for common and complex disorders in this population.

Detailed Description

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This is a single site, 8-week, double-blinded, placebo lead-in trial with fluoxetine or desipramine. All subjects have a comprehensive psychiatric and medical assessment, and if enrolled, continued with two consecutive phases of the study: 1) A one-week, single-blind placebo lead-in phase to eliminate placebo responders. 2) Subsequent random assignment to one of two treatment groups: fluoxetine 10-40 mg/day or desipramine 50-200 mg/day. Given the proven efficacy of these antidepressant medications, a placebo lead-in period followed by active treatment for all patients has been utilized in order to minimize human subjects at risk.

Conditions

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Major Depressive Disorder Major Depression Unipolar Depression

Keywords

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Depression mood disorders affective disorders pharmacogenetics pharmacogenomics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Interventions

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fluoxetine or desipramine

fluoxetine 5-40 mg/day desipramine 50-150 mg/day

Intervention Type DRUG

Other Intervention Names

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Prozac

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role lead

Responsible Party

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University of Miami

Principal Investigators

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Julio Licinio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Center for Pharmacogenomics, University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

References

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Flores DL, Alvarado I, Wong ML, Licinio J, Flockhart D. Clinical implications of genetic polymorphism of CYP2D6 in Mexican Americans. Ann Intern Med. 2004 Jun 1;140(11):W71. doi: 10.7326/0003-4819-140-11-200406010-00028-w2. No abstract available.

Reference Type BACKGROUND
PMID: 15172931 (View on PubMed)

Licinio J, O'Kirwan F, Irizarry K, Merriman B, Thakur S, Jepson R, Lake S, Tantisira KG, Weiss ST, Wong ML. Association of a corticotropin-releasing hormone receptor 1 haplotype and antidepressant treatment response in Mexican-Americans. Mol Psychiatry. 2004 Dec;9(12):1075-82. doi: 10.1038/sj.mp.4001587.

Reference Type RESULT
PMID: 15365580 (View on PubMed)

Wong ML, Arcos-Burgos M, Liu S, Licinio AW, Yu C, Chin EWM, Yao WD, Lu XY, Bornstein SR, Licinio J. Rare Functional Variants Associated with Antidepressant Remission in Mexican-Americans: Short title: Antidepressant remission and pharmacogenetics in Mexican-Americans. J Affect Disord. 2021 Jan 15;279:491-500. doi: 10.1016/j.jad.2020.10.027. Epub 2020 Oct 17.

Reference Type DERIVED
PMID: 33128939 (View on PubMed)

Wong ML, Dong C, Flores DL, Ehrhart-Bornstein M, Bornstein S, Arcos-Burgos M, Licinio J. Clinical outcomes and genome-wide association for a brain methylation site in an antidepressant pharmacogenetics study in Mexican Americans. Am J Psychiatry. 2014 Dec 1;171(12):1297-309. doi: 10.1176/appi.ajp.2014.12091165. Epub 2014 Oct 31.

Reference Type DERIVED
PMID: 25220861 (View on PubMed)

Licinio J, Dong C, Wong ML. Novel sequence variations in the brain-derived neurotrophic factor gene and association with major depression and antidepressant treatment response. Arch Gen Psychiatry. 2009 May;66(5):488-97. doi: 10.1001/archgenpsychiatry.2009.38.

Reference Type DERIVED
PMID: 19414708 (View on PubMed)

Other Identifiers

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U01GM061394

Identifier Type: NIH

Identifier Source: org_study_id

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