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Predictive Diagnostic Test for Anti-Depressant Related Suicide Risk

Posted Sep 30 2007 5:00pm

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.

Diagnostic tests predicting the likelihood of suicide during anti-depressant treatment.

Development Status:
Clinical data.

Francis J McMahon (NIMH)

Patent Status:
HHS, Reference No. E-157-2006/0
US, Application No. 60/854,978 filed 27 Oct 2006
US, Application No. 11/925,334 filed 27 Oct 2007

Relevant Publication:
  1. 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 for more information.

Gene Based Therapies
Gene Based Therapies - Diagnostics

For Additional Information Please Contact:
Norbert Pontzer Ph.D., J.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325 Room 23,
Rockville, MD 20852
United States
Phone: 301-435-5502
Fax: 301-402-0220

Ref No: 1670

Updated: 10/2007

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