An interventional study of IDgenetix Neuropsychiatric Test Panel in Depression and Anxiety, sponsored by AltheaDx. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-29.
Sponsored by AltheaDx · Not applicable, Interventional, and Diagnostic
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.
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.
8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's planned enrollment of 220 is above the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →AltheaDx is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 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.
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.
Also known as: PGx Testing
Comparison of change in neuropsychiatric state between the two treatment arms measured by Neuropsychiatric Questionnaire (NPQ)
Neuropsychiatric Questionnaire (NPQ) score change comparison between the two treatment arms over a 4-month period.
Time frame: 4 months
Comparison of change in responsiveness between the two treatment arms measured by Symbol Digit Coding (SDC) test
Symbol Digit Coding (SDC) test score change comparison between the two treatment arms over a 4-month period.
Time frame: 4 months
Comparison of hospital utilization between the two treatment arms as measured by hospital admission and re-admission rates
Comparison of hospital utilization, as measured by hospital admission and re-admission rates, 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
Comparison of adverse drug events between the two treatment arms over a 4-month period
Time frame: 4 months
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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