Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Anxiety, Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | March 2015 |
| End Date: | December 2015 |
Prospective Randomized Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders
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.
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.
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.
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.
Inclusion Criteria:
- Male or female subjects between the ages of 18 and 80
- Experiencing or showing evidence of a neuropsychiatric disorder (depression, anxiety,
attention deficit hyperactivity disorder and psychosis) as determined by a qualified
clinician
- Subjects new to the medical provider
- Willing and able to comply with study procedures
- Able to provide written informed consent
Exclusion Criteria:
- Unwilling or unable to provide written informed consent and to comply with study
procedures
- Any subject for whom providing a buccal swab sample would be contraindicated or not
possible
- Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4
or 5)
- Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to
anticoagulant medications, aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) >1.5x normal, or suspected cirrhosis
- History of malabsorption (short gut syndrome)
- Any gastric or small bowel surgery less than 3 months prior to study enrollment
- Subject is being treated with intravenous medication
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