Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders

NCT ID: NCT02411123

Last Updated: 2015-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-12-31

Brief 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.

Conditions

Depression; Anxiety

Keywords

PGx; pharmacogenetics; depression; anxiety; Neuropsychiatric diseases; IDgenetix; AltheaDx

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

IDgenetix Neuropsychiatric Test Panel

Intervention Type: GENETIC

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: GENETIC

Other Intervention Names

PGx Testing

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carolina Partners in Mental Healthcare

UNKNOWN

Sponsor Role: collaborator

AltheaDx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Carolina Partners in Mental HealthCare

Raleigh, North Carolina, United States

Countries

United States

References

Masand PS. Tolerability and adherence issues in antidepressant therapy. Clin Ther. 2003 Aug;25(8):2289-304. doi: 10.1016/s0149-2918(03)80220-5.

Reference Type: BACKGROUND

PMID: 14512135 (View on PubMed)

Crisafulli C, Fabbri C, Porcelli S, Drago A, Spina E, De Ronchi D, Serretti A. Pharmacogenetics of antidepressants. Front Pharmacol. 2011 Feb 16;2:6. doi: 10.3389/fphar.2011.00006. eCollection 2011.

Reference Type: BACKGROUND

PMID: 21687501 (View on PubMed)

Mrazek DA. Psychiatric pharmacogenomic testing in clinical practice. Dialogues Clin Neurosci. 2010;12(1):69-76. doi: 10.31887/DCNS.2010.12.1/dmrazek.

Reference Type: BACKGROUND

PMID: 20373668 (View on PubMed)

Serretti A, Kato M, De Ronchi D, Kinoshita T. Meta-analysis of serotonin transporter gene promoter polymorphism (5-HTTLPR) association with selective serotonin reuptake inhibitor efficacy in depressed patients. Mol Psychiatry. 2007 Mar;12(3):247-57. doi: 10.1038/sj.mp.4001926. Epub 2006 Dec 5.

Reference Type: BACKGROUND

PMID: 17146470 (View on PubMed)

Olson MC, Maciel A, Gariepy JF, Cullors A, Saldivar JS, Taylor D, Centeno J, Garces JA, Vaishnavi S. Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial. Prim Care Companion CNS Disord. 2017 Mar 16;19(2). doi: 10.4088/PCC.16m02036.

Reference Type: DERIVED

PMID: 28314093 (View on PubMed)

Other Identifiers

CLP0002

Identifier Type: -

Identifier Source: org_study_id