Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders
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|ClinicalTrials.gov Identifier: NCT02411123|
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : December 29, 2015
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as depression and anxiety, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their treatment.
This study will also evaluate whether pharmacogenetic (PGx) testing can reduce adverse drug events, hospitalization rates, hospital length of stay, emergency room visits, disability, death or other serious drug side effects.
|Condition or disease||Intervention/treatment||Phase|
|Depression Anxiety||Genetic: IDgenetix Neuropsychiatric Test Panel||Not Applicable|
Anti-depressant and anti-anxiety medications are still administered by a trial and error method, which results in a substantial number of patients suffering from either a lack of benefit from drug therapy or severe side effects. Approximately 40% of all anti-depressant and anti-anxiety medications prescribed are ineffective, and patients who need to be on medication often discontinue taking their medications, which can have potentially dangerous consequences. Clinical features often fail to predict the drug response and tolerability of a patient to a prescription medication.
Genetics can help guide therapeutic decisions for patients exhibiting neuropsychiatric disorders and improve patient outcomes by maximizing drug efficacy and minimizing the risk of adverse events. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.
Pharmacogenetic-guided therapy selection using the IDgenetix Neuropsychiatric Test Panel can enhance patient response and tolerability by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.
In this prospective, randomized, single-blind study, new patients presenting to the clinical site with evidence of depression or anxiety as determined by a qualified clinician will be invited to participate. Study participants will be randomized to one of two groups with respect to the IDgenetix Neuropsychiatric Test Panel result: group with testing results revealed to the medical provider prior to treatment selection (Experimental Group) or group without testing results prior to treatment selection (Control Group). Participant outcomes will be measured at baseline and throughout the 4-month duration of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Randomized Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||December 2015|
Experimental: IDgenetix Neuropsychiatric Test Panel Intervention
The medical provider for the IDgenetix Neuropsychiatric Test Panel-guided group will make treatment recommendations based on test results. Patient outcomes will be measured throughout the duration of the study.
Genetic: IDgenetix Neuropsychiatric Test Panel
The IDgenetix Neuropsychiatric Test Panel is used to make recommendations on the medication therapy that might be impacted by the genetic background of the patient.
Other Name: PGx Testing
No Intervention: control
The medical provider for the control group will not receive IDgenetix Neuropsychiatric Test Panel results and will make treatment recommendations as usual. Patient outcomes will be measured throughout the duration of the study.
- Comparison of change in neuropsychiatric state between the two treatment arms measured by Neuropsychiatric Questionnaire (NPQ) [ Time Frame: 4 months ]Neuropsychiatric Questionnaire (NPQ) score change comparison between the two treatment arms over a 4-month period.
- Comparison of change in responsiveness between the two treatment arms measured by Symbol Digit Coding (SDC) test [ Time Frame: 4 months ]Symbol Digit Coding (SDC) test score change comparison between the two treatment arms over a 4-month period.
- Comparison of hospital utilization between the two treatment arms as measured by hospital admission and re-admission rates [ Time Frame: 4 months ]Comparison of hospital utilization, as measured by hospital admission and re-admission rates, between the two treatment arms over a 4-month period.
- Comparison of adverse drug events between the two treatment arms over a 4-month period [ Time Frame: 4 months ]Comparison of adverse drug events between the two treatment arms over a 4-month period
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 ClinicalTrials.gov identifier (NCT number): NCT02411123
|United States, North Carolina|
|Carolina Partners in Mental HealthCare|
|Raleigh, North Carolina, United States, 27609|