Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): IDgenetix Neuropsychiatric Test Panel
Intervention type(s): Genetic
Intervention description(s): 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 intervention name(s): PGx Testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: PGx; pharmacogenetics; depression; anxiety; Neuropsychiatric diseases; IDgenetix; AltheaDx