NCT00265291|CompletedPhase 2DMC
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Sponsor study identifier
NIH
interventional
700
1 country
1
Study Start
November 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2006
Actual (reported)Study Completion
October 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1999
Date type not reportedThis date has not been verified as actual or estimated.
December 13, 2005
Actual (reported)December 14, 2005
Actual (reported)May 2006
Actual (reported)October 2008
Actual (reported)The Hamilton Depression Rating Scale (HAM-D) on a weekly basis
8 weeks
The Hamilton Anxiety Rating Scales (HAM-A), the Global Assessment Scale (GAS), the Beck Depression Inventory (BDI), and the Center for Epidemiological Depression Rating Scale (CES-D) on a weekly basis
8 weeks
fluoxetine 5-40 mg/day desipramine 50-150 mg/day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
fluoxetine or desipramine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordContact the study team to confirm eligibility.
Center for Pharmacogenomics, University of Miami
Miami, Florida, 33136, United States
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.
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.
Julio Licinio, MD
University of Miami
700 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2005
First Posted
December 14, 2005
Study Start
November 1999
Date type not reportedThis date has not been verified as actual or estimated.
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.
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.
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.
Primary Completion
May 2006
Actual (reported)Study Completion
October 2008
Actual (reported)Last Updated
October 10, 2008
Record last verified: 2008-09
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Source: ClinicalTrials.gov.
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