Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic
Condition: Obsessive Compulsive Disorder; Major Depressive Disorder; Anxiety
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Observational

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.
    

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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists children and adolescents ages 8 to 20 who are receiving
        medication treatment for a mood disorder, anxiety disorder, or obsessive compulsive
        disorder.
      
Biospecimen description: 
      Whole blood
    
Keywords: Pharmacogenomic; child; psychiatry; Obsessive Compulsive Disorder; Depression; Anxiety; CYP2D6; CYP2C19; Selective serotonin reuptake inhibitor; SSRI