Pharmacogenomics of Antidepressant Response in Children and Adolescents

Completed

• Conditions: Eating Disorders; Obsessive-Compulsive Disorder; Suicide Prevention; Anxiety Disorders; Depression

• Registration Number: NCT00516932
• Lead Sponsor: Duke University

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.

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:

1. To establish a genetic susceptibility database by creating a DNA repository of 120 patients with a prospectively identified "Suicidal Event" and 360 closely matched antidepressant-tolerant controls, including rigorous phenotypic characterization of these patients;

2. To establish a genetic susceptibility database by creating a DNA repository of 120 patients with prospectively identified "Behavioral Activation" and 360 closely matched antidepressant-tolerant controls, including rigorous phenotypic characterization of these patients;

3. To establish a genetic susceptibility database by creating a DNA repository of 120 patients with prospectively identified co-occurring "Suicidal Event and Behavioral Activation" and 360 closely matched antidepressant-tolerant controls, including rigorous phenotypic characterization of these patients;

4. To identify genetic polymorphisms responsible for the development of "Suicidal Events" using a candidate gene approach, including biosynthetic pathways, metabolizing enzymes, transporters, ion channels, and receptors;

5. To identify genetic polymorphisms responsible for the development of "Behavioral Activation" using a candidate gene approach, including biosynthetic pathways, metabolizing enzymes, transporters, ion channels, and receptors;

6. To use these data along with data from the parent study, ASK, to better understand the relationship between "Suicidal Events" and "Behavioral Activation."

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-16
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	9 months

Trial Locations

Locations (1)

Child and Adolescent Psychiatry Trials Network (CAPTN); 🇺🇸 Durham, North Carolina, United States