Clinical Study Evaluating Effects of Pharmacogenetic-guided vs Standard-of-Care Treatment on Depression and/or Anxiety

December 16, 2016 updated by: AltheaDx

A Prospective, Multi-Center, Randomized Clinical Study to Evaluate the Clinical Impact of Pharmacogenetic-Guided Treatment for Depression & Anxiety

A prospective, multi-center, randomized, subject and outcome evaluator blind , parallel-group study evaluating the effect of pharmacogenetic-guided versus standard of care treatment for subjects diagnosed with depression and/or anxiety disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A substantial number of patients taking anti-depressant and anti-anxiety medications suffer from either a lack of benefit from drug therapy or severe side effects. 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 potentially 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.

This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed treatment. 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, multi-center, randomized, subject and outcome evaluator blind, parallel-group study patients presenting to the clinical site with evidence of depression and/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 3-month duration of the study.

Study Type

Interventional

Enrollment (Actual)

579

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Rolling Hills, California, United States
        • Adnab Research
      • San Diego, California, United States
        • Artemis Clinical Research
      • Torrance, California, United States
        • Adnab Research
      • Torrance, California, United States
        • Collaborative NeuroScience Network
    • Florida
      • Lauderhill, Florida, United States
        • Innovative Clinical Research
      • Miami, Florida, United States
        • Innova Clinical Trials
      • Orlando, Florida, United States
        • APG Research
    • Georgia
      • Decatur, Georgia, United States
        • iResearch Atlanta
      • Savannah, Georgia, United States
        • Meridian Clinical Research
    • Louisiana
      • Metairie, Louisiana, United States
        • MedPharmics
    • Nebraska
      • Norfolk, Nebraska, United States
        • Meridian Clinical Research
    • New York
      • Binghamton, New York, United States
        • United Medical Associates
      • Staten Island, New York, United States
        • Richmond Behavioral Associates
    • North Carolina
      • Raleigh, North Carolina, United States
        • Carolina Partners in Mental HealthCare
    • Pennsylvania
      • Lansdale, Pennsylvania, United States
        • Detweiler Family Medicine
    • Texas
      • Dallas, Texas, United States
        • Relaro Medical Trials
    • Virginia
      • Virginia Beach, Virginia, United States
        • Tidewater Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects 18 years of age or older.

  • Subjects diagnosed with depression and/or anxiety as per the DSM-V criteria or standard of care site procedures and meeting at least one of the following:

    • Diagnosed with depression and/or anxiety either new to treatment or currently taking medications for less than 6 weeks.
    • Inadequately controlled with medications defined as inadequate efficacy after 6 weeks of a psychotropic treatment or have discontinued psychotropic treatment due to adverse events or intolerability.
  • 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 patient for whom providing a buccal swab sample would be contraindicated or not possible.
  • Subjects diagnosed as not having anxiety or depression.
  • Patients at significant risk for suicide and/or in need of immediate hospitalization as judged by the investigator.
  • Diagnosis of Bipolar Disorder, as assessed by patient history or M.I.N.I. response.
  • Diagnosis of Schizophrenia or Schizoaffective disorder, as assessed by patient history or M.I.N.I. response.
  • History or diagnosis of a personality disorder, as assessed by patient history or M.I.N.I. response.
  • History of physical traumatic injury (i.e., TBI) resulting in depression.
  • Patients new to psychotherapy (provided by licensed and trained mental health professionals) or have not been on a stable psychotherapy regimen for at least 8 weeks.
  • Patients receiving other alternative treatments such as Electroconvulsive Therapy (ECT), Transcranial Magnetic Stimulation (TMS), Vagal Nerve Stimulation (VNS), and Deep Brain Stimulation (DBS).
  • Patients with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5).
  • Patients with abnormal hepatic function within the last 2 years, (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis).
  • Patients with a history of malabsorption (short gut syndrome).
  • Patients with any gastric or small bowel surgery less than 3 months prior to study enrollment.
  • Patients with significant unstable medical condition, neurological disorders (e.g. epilepsy, Parkinson's disease or stroke) or life threatening disease.
  • Patients who are currently being treated for anxiety and /or depression incorporating pharmacogenetic information.
  • History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months.
  • Patients with any significant substance use disorder as assessed by M.I.N.I. response and judged by the investigator.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDgenetix Neuropsychiatric Test Panel Intervention
Medical providers for 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 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 Names:
  • PGx Testing
No Intervention: Control Group
Medical providers 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The reduction of adverse drug events (ADE) subsequent to pharmacogenetics-guided treatment as compared to standard of care for treatment of depression and/or anxiety symptoms.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Hamilton Rating Scale for Depression (HAMD-17) score from baseline.
Time Frame: 12 weeks
12 weeks
Change in the Hamilton Rating Scale for Anxiety (HAM-A) score from baseline.
Time Frame: 12 weeks
12 weeks
Percentage of depression subjects who respond (≥50% decrease in HAM-D17 from baseline or remit, HAM-D17 total score ≤7).
Time Frame: 12 weeks
12 weeks
Percentage of anxiety subjects who respond (≥50% decrease in HAM-A from baseline or remit, HAM-A total score ≤7)
Time Frame: 12 weeks
12 weeks
Time to response/remission of depressive symptoms.
Time Frame: 12 weeks
12 weeks
Time to response/remission of anxiety symptoms.
Time Frame: 12 weeks
12 weeks
Medication change: Number of subjects who changed their antidepressant and anxiety medication regimens from baseline.
Time Frame: 12 weeks
12 weeks
The impact of pharmacogenetic-guided treatment.care costs as measured by HMWDQ
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AltheaDx

Collaborators

Innovis LLC

Investigators

  • Study Director: Joel Centeno, AltheaDx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-0009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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