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| Descriptive Information Fields | |||||||||
| Brief Title † | Pharmacogenomics of Antidepressant Response in Children and Adolescents | ||||||||
| Official Title † | Pharmacogenomics of Antidepressant Response in Children and Adolescents | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Prospective | ||||||||
| Primary Outcome Measure † | Suicidal Event(120 patients) Behavioral Activation(120 patients) Co-occurring Suicidal Event + Behavioral Activation (120 patients) Tolerant controls (at a control to case ratio of 3:1)no evidence of Suicidal Events or Behavioral Activation [ Time Frame: 9 months ] | ||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Anxiety Disorders Depression Eating Disorders Obsessive-Compulsive Disorder Suicide Prevention |
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| Intervention † | |||||||||
| MEDLINE PMIDs | |||||||||
| Links | Click here for the Child and Adolescent Psychiatry Trials Network Web site ![]() Click here for the ASK study, a related trial within the CAPTN network  ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 2179 | ||||||||
| Start Date † | May 2007 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
Note: Tolerant controls will be ineligible if they have a past history of a treatment-emergent "Suicidal Event" or "Behavioral Activation" |
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| Gender | Both | ||||||||
| Ages | 7 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00516932 | ||||||||
| Organization ID | P30 MH66386-01 | ||||||||
| Secondary IDs †† | DSIR CTM | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2007 | ||||||||
| First Received Date † | August 14, 2007 | ||||||||
| Last Updated Date | January 29, 2008 | ||||||||