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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02855580
Other study ID # IRB201601035
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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