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

NCT02411123 | Completed

• 1 other identifier: CLP0002
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 months

Secondary Outcomes (2)

• Comparison of hospital utilization between the two treatment arms as measured by hospital admission and re-admission rates

  4 months

• Comparison of adverse drug events between the two treatment arms over a 4-month period

  4 months

Study Arms (2)

IDgenetix Neuropsychiatric Test Panel Intervention

EXPERIMENTAL

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

control

NO INTERVENTION

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.

Interventions

IDgenetix Neuropsychiatric Test Panel 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.

Also known as: PGx Testing

IDgenetix Neuropsychiatric Test Panel Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AltheaDx: lead
• Carolina Partners in Mental Healthcare: collaborator

Study Sites (1)

Carolina Partners in Mental HealthCare

Raleigh, North Carolina, 27609, United States

Location

Related Publications (5)

• 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.

  PMID: 14512135 BACKGROUND

• 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.

  PMID: 21687501 BACKGROUND

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

  PMID: 20373668 BACKGROUND

• 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.

  PMID: 17146470 BACKGROUND

• 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.

  PMID: 28314093 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 8, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

US (1)