Anxiety Clinical Trial
— PGXOfficial title:
Integrating Pharmacogenomic Testing Into a Child Psychiatry Clinic
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 |
Verified date | June 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Child Psychiatry Clinic at University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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