Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic

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.

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