Predictive Diagnostic Test for Anti-Depressant Related Suicide Risk
Description of Invention:
A number of studies have reported a potential link between antidepressant treatment and suicides. Although the scientific basis for this phenomenon is not known, the Food and Drug Administration (FDA) required a black box warning of worsening depression and/or emergence of suicidality (i.e., development of suicidal thoughts or behavior) in both adult and pediatric patients taking several antidepressants. While use of antidepressants fell subsequent to the black box warning, recent studies suggest that pediatric suicides may actually be rising. This has led to concerns that untreated depression due to the black box warning could potentially result in an overall increase in suicides.
To determine whether a genetic basis for suicidal risk exists for a sub-group of depressed patients, NIH researchers genetically screened patients with major depression treated with the serotonin selective reuptake inhibitor (SSRI) citalopram (Celexa) in the NIMH-funded Sequenced Treatment Alternatives for Depression (STAR*D) trial. Versions of two genes coding for components of the brain's glutamate chemical messenger system were linked to suicidal thinking associated with antidepressant use. Having both implicated versions increased risk of such thoughts more than 14-fold. By identifying those patients who need close monitoring, alternative treatments and/or specialty care, these genetic tests should prevent the under prescribing of anti-depressant drugs and the resulting possibility of suicide due to sub-optimal treatment.
Applications:
Diagnostic tests predicting the likelihood of suicide during anti-depressant treatment.
Market:
Depression ranks among the ten leading causes of disability and will become the second-largest cause of the global health burden by 2020. An estimated 121 million people worldwide suffer from a depressive disorder for which they require treatment. It is estimated that 5.8% of all men and 9.5% of all women will suffer from a depressive disorder in any given year and that 17% of all men and women will suffer from a depressive disorder at some point in their lives.
Patent Status:
DHHS Reference No. E-157-2006/0 --
U.S. Provisional Application No. 60/854,978 filed 27 Oct 2006
Relevant Publication: G Laje et al. Genetic markers of suicidal ideation emerging during citalopram treatment of major depression. Am J Psychiatry. 2007 Oct;164(10):1530-1538. [PubMed abs]
Licensing Status: Available for licensing.
Collaborative Research Opportunity:
The National Institute of Mental Health Mood and Anxiety Disorders Program Genetics Unit is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the Predictive Diagnostic Test for Anti-Depressant Related Suicide. Please contact Dr. Francis McMahon at mcmahonf@mail.nih.gov for more information.
Portfolios: Gene Based Therapies
Gene Based Therapies -Diagnostics
For Additional Information Please Contact: Norbert J. Pontzer PhD JD
NIH Office of Technology Transfer
6011 Executive Blvd, Suite 325
Rockville, MD 20852-3804
Phone: (301) 435-5502
Email: pontzern@mail.nih.gov
Fax: (301) 402-0220
