PGX: Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02855580

Collaborator

(none)

Enrollment

Location

10.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder Major Depressive Disorder Anxiety

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

71 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Jul 6, 2017

Actual Study Completion Date :

Jul 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
PGX Testing Based Treatment Treatment will be administered based on the results that are obtained from the pharmacogenomics testing. Results from testing will be provided two weeks after specimen collection.
Standard of Care Treatment Treatment will be based off of the standard of care. Results from pharmacogenomics testing will be provided at the end of the study.

Outcome Measures

Primary Outcome Measures

Antidepressant Tolerance [From week 0 through week 12]
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.

Secondary Outcome Measures

Symptom Severity-Depression [From week 0 through week 12]
Depression will be assessed using the Children's Depression Inventory (CDI)
Symptom Severity-Anxiety [From week 0 through week 12]
Anxiety will be assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Symptom Severity-Obsessive Compulsive Symptoms [From week 0 through week 12]
Obsessive compulsive symptoms will be assessed using the Children's Florida Obsessive Compulsive Inventory (C-FOCI).
Side effects [From week 1 through week 12]
Assess effects associated with AD treatment using a standardized questionnaire commonly used in clinical trials of children and modified for this study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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