Obsessive Compulsive DisorderPGXNCT02855580
Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic
An observational study of Obsessive Compulsive Disorder and Major Depressive Disorder, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder, Major Depressive Disorder, Anxiety
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 6 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Psychiatry Clinic at University of Florida
Gainesville, Florida, 32606
About this study
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.
Read the 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.
- Keywords
- Pharmacogenomic, child, psychiatry, Obsessive Compulsive Disorder, Depression, Anxiety, CYP2D6, CYP2C19, Selective serotonin reuptake inhibitor, SSRI
- Medical subject headings
- Obsessive-Compulsive Disorder, Depressive Disorder, Major, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From week 0 through week 12
Secondary outcomes (4)
Symptom Severity-Depression
Depression will be assessed using the Children's Depression Inventory (CDI)
Measured: From week 0 through week 12
Symptom Severity-Anxiety
Anxiety will be assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Measured: From week 0 through week 12
Symptom Severity-Obsessive Compulsive Symptoms
Obsessive compulsive symptoms will be assessed using the Children's Florida Obsessive Compulsive Inventory (C-FOCI).
Measured: From week 0 through week 12
Side effects
Assess effects associated with AD treatment using a standardized questionnaire commonly used in clinical trials of children and modified for this study.
Measured: From week 1 through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol A Mathews, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855580
- Sponsor's protocol ID
- IRB201601035
- Acronym
- PGX
- Status last verified
- Jun 2019
- First submitted
- 19 Jul 2016
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic
- ClinicalTrials.gov ID
- NCT02855580
- Acronym / sponsor ID
- PGX / IRB201601035
- Keywords
- Pharmacogenomic, child, psychiatry, Obsessive Compulsive Disorder, Depression, Anxiety, CYP2D6, CYP2C19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Symptom Severity-Depression
Time frame: From week 0 through week 12
Symptom Severity-Anxiety
Time frame: From week 0 through week 12
Symptom Severity-Obsessive Compulsive Symptoms
Time frame: From week 0 through week 12
Side effects
Time frame: From week 1 through week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Carol A. Mathews, MD Research Lab InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol A Mathews, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive Compulsive Disorder and Major Depressive Disorder, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antidepressant Tolerance (time frame: From week 0 through week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.