National Institute of Mental Health (NIMH)
|Information provided by:||National Institute of Mental Health (NIMH)|
This study will identify variations in genes that may be involved in the development of suicidal events or certain behaviors in youth who are exposed to antidepressant medications.
|Official Title:||Pharmacogenomics of Antidepressant Response in Children and Adolescents|
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||December 2010|
Pharmacogenomics of Antidepressant Response in Children and Adolescents (PARCA) is a sub-study of the Antidepressant Safety in Kids (ASK) study. PARCA and ASK are part of the Child and Adolescent Psychiatry Trials Network (CAPTN).
Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications are prescribed to approximately 2 to 3% of American children. Evidence suggests that these medications are beneficial for treating obsessive-compulsive disorder (OCD), anxiety disorders, and major depressive disorder. Following hearings in February and September of 2004, the FDA mandated Black Box warnings for all antidepressants, cautioning prescribers about the risk of treatment-emergent suicidal tendency in children and adolescents treated with these drugs. Although prescribing waned somewhat following the warning, many children continue to receive SSRIs and SNRIs for a variety of conditions that do not have empirically validated alternative treatments. Therefore, there is a pressing need to clearly understand the safety, tolerability, and effectiveness of SSRIs and SNRIs in children and adolescents. This study will identify variations in differentially expressed genes that may be involved in the development of suicidal events and certain behaviors in youth exposed to antidepressant medications.
Specific aims of the study include the following:
Participants will include participants of the ASK study who want to participate in the PARCA study. Participants will use a self-collection kit to provide a saliva sample. The saliva sample will be mailed to the study center for DNA analysis. There will be no study visits.
|Contact: Onur N. Karayal, MD, MPHemail@example.com|
|Contact: John S. March, MD, MPHfirstname.lastname@example.org|
|United States, North Carolina|
|Child and Adolescent Psychiatry Trials Network (CAPTN)||Recruiting|
|Durham, North Carolina, United States, 27715|
|Contact: Onur N. Karayal, MD, MPH 919-668-7823 email@example.com|
|Contact: John S. March 919-416-2404 firstname.lastname@example.org|
|Principal Investigator: John S. March, MD, MPH|
|Principal Investigator:||John S. March, MD, MPH||Professor and Chief, Child and Adolescent Psychiatry; Program for Child Affective and Anxiety Disorders; Duke University Child and Family Study Center|