![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00516932 |
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.
Condition |
---|
Anxiety Disorders Depression Eating Disorders Obsessive-Compulsive Disorder Suicide Prevention |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Pharmacogenomics of Antidepressant Response in Children and Adolescents |
Salivary DNA retained at the Duke Center for Human Genetics
Estimated Enrollment: | 2179 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Males and Females
Age 7 -17 years
Pre-specified disorder of anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder.
Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
Patients may receive adjunctive TCA treatment during the study at the clinician's discretion.
Note: Tolerant controls will be ineligible if they have a past history of a treatment-emergent "Suicidal Event" or "Behavioral Activation"
Contact: Jerry L. Kirchner, BS, CCRP | 919-668-7818 | jerry.kirchner@duke.edu |
Contact: John S. March, MD, MPH | 919-668-4644 | john.march@duke.edu |
United States, North Carolina | |
Child and Adolescent Psychiatry Trials Network (CAPTN) | Recruiting |
Durham, North Carolina, United States, 27715 | |
Contact: Jerry L. Kirchner, BS, CCRP 919-668-7818 jerry.kirchner@duke.edu | |
Contact: John S. March, MD, MPH 919-668-4644 john.march@duke.edu | |
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 |
Responsible Party: | Duke University Medical Center ( John S. March, MD, MPH ) |
Study ID Numbers: | P30 MH066386-01, DSIR CTM 4398; Pro00001300 |
Study First Received: | August 14, 2007 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00516932 History of Changes |
Health Authority: | United States: Federal Government |
Suicidal Event Behavioral Activation |
Depression Anxiety Disorders Mental Disorders Psychotropic Drugs Suicide Depressive Disorder |
Antidepressive Agents Eating Disorders Obsessive-Compulsive Disorder Self-Injurious Behavior Behavioral Symptoms |
Depression Disease Psychotropic Drugs Suicide Pharmacologic Actions Behavioral Symptoms Pathologic Processes Anxiety Disorders |
Mental Disorders Therapeutic Uses Central Nervous System Agents Eating Disorders Obsessive-Compulsive Disorder Antidepressive Agents Self-Injurious Behavior |