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Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic (PGX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02855580
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : June 10, 2019
Information provided by (Responsible Party):
University of Florida

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
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.

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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 : September 2016
Actual Primary Completion Date : July 6, 2017
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Antidepressant Tolerance [ Time Frame: 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 :
  1. Symptom Severity-Depression [ Time Frame: From week 0 through week 12 ]
    Depression will be assessed using the Children's Depression Inventory (CDI)

  2. Symptom Severity-Anxiety [ Time Frame: From week 0 through week 12 ]
    Anxiety will be assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED)

  3. Symptom Severity-Obsessive Compulsive Symptoms [ Time Frame: From week 0 through week 12 ]
    Obsessive compulsive symptoms will be assessed using the Children's Florida Obsessive Compulsive Inventory (C-FOCI).

  4. Side effects [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02855580

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United States, Florida
Child Psychiatry Clinic at University of Florida
Gainesville, Florida, United States, 32606
Sponsors and Collaborators
University of Florida
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Principal Investigator: Carol A Mathews, MD University of Florida

Additional Information:
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Responsible Party: University of Florida Identifier: NCT02855580     History of Changes
Other Study ID Numbers: IRB201601035
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Obsessive Compulsive Disorder
Selective serotonin reuptake inhibitor
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Personality Disorders
Anxiety Disorders