Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic

Anxiety Clinical Trial

— PGX  

Official title:

Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855580
• Other study ID #: IRB201601035
• Status: Completed
• Start date: September 2016
• Est. completion date: July 6, 2017

Study information

• Verified date: June 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the feasibility, acceptability, and utility of pharmacogenomic (PGX) testing (specifically for the cytochrome P450 2D6 and 2C19 genes) prior to initiating treatment with an antidepressant (AD) among children and adolescents in the University of Florida Child Psychiatry clinics.

Description:

This project will assess the feasibility of implementing pharmacogenomic testing (PGX) for specific genes involved in the metabolism of antidepressants (CYP2D6 and CYP2C19) into the child psychiatry clinic at UF.

Although not widely implemented to date, naturalistic studies in adult psychiatry populations have shown that PGX testing can improve patient outcomes, increase medication adherence, and reduce costs. However, there have been no studies of psychiatry-focused PGX testing in children. One in every four children and adolescents suffers from a mental illness (more than half have a mood or anxiety disorder) that is severe enough to impact their functioning at school, at home, or in other important areas. Although psychotherapy remains the first line treatment for children with mild or uncomplicated symptoms, the use of psychotropic medications in children has increased steadily over the last decade. These medications are effective for many children, but carry a substantial risk of side effects, including gastrointestinal, cognitive, systemic, and psychiatric (including treatment emergent suicidal ideation). For most treatment responders, improvement is typically seen four to eight weeks after the target dose has been achieved (twelve weeks for obsessive compulsive disorder). Thus, identifying the best medication options prior to treatment initiation could decrease the likelihood of side effects severe enough to require medication discontinuation or changes, and minimize the time to response. In this study, 50 children and adolescents with major depression, anxiety, or obsessive compulsive disorders who are beginning treatment with a new antidepressant will be recruited and PGX testing will be conducted. Twenty five children will be randomized to receive PGX testing prior to starting/changing medications and 25 to receive treatment as usual (these children will receive their PGX results at the end of 12 weeks). Members of the UF Health Personalized Medicine Program will provide education to the prescribing clinicians about PGX testing and will create patient-specific consultations regarding the PGX results.

Assess clinicians' and parents' willingness to use PGX testing in making treatment decisions, as well as their knowledge and beliefs about PGX testing (pre-and post-study). Also assess, as pilot data for a larger randomized controlled trial, differences in side effect profiles, treatment adherence, and symptom improvements between the PGX cases and controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 6, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 20 Years

Eligibility

Inclusion Criteria:

• Male or female age 8 to 20 years old

• Have been diagnosed with and receiving treatment for mood disorder, anxiety, or obsessive compulsive disorder

• Receiving treatment at UF child psychiatry clinic

Exclusion Criteria:

• Children with a primary diagnosis of autism

• High risk for suicide

• Children determined by UF psychiatrist to be too ill to tolerate waiting two weeks to begin medication treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Locations

Country	Name	City	State
United States	Child Psychiatry Clinic at University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antidepressant Tolerance	The feasibility of pharmacogenomic (PGX) testing (specifically for the cytochrome P450 and 2C19 genes) prior to initiating treatment in a child and adolescent population will be measured through medication compliance and frequency of medication changes as described in the patient's medical record.	From week 0 through week 12
Secondary	Symptom Severity-Depression	Depression will be assessed using the Children's Depression Inventory (CDI)	From week 0 through week 12
Secondary	Symptom Severity-Anxiety	Anxiety will be assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED)	From week 0 through week 12
Secondary	Symptom Severity-Obsessive Compulsive Symptoms	Obsessive compulsive symptoms will be assessed using the Children's Florida Obsessive Compulsive Inventory (C-FOCI).	From week 0 through week 12
Secondary	Side effects	Assess effects associated with AD treatment using a standardized questionnaire commonly used in clinical trials of children and modified for this study.	From week 1 through week 12

External Links

•   Carol A. Mathews, MD Research Lab Information