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

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IDgenetix Neuropsychiatric Test Panel
Sponsored by
AltheaDx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Depression focused on measuring Pharmacogenetic testing, PGx, Depression, Neuropsychiatric diseases, IDgenetix, AltheaDx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Adnab Research
  • Artemis Clinical Research
  • Adnab Research
  • Collaborative Neuroscience Network
  • Innovative Clinical Research
  • Innova Clinical Trials
  • APG Research
  • iResearch Atlanta
  • Meridian Clinical Research
  • Medpharmics
  • Meridian Clinical Research
  • United Medical Associates
  • Richmond Behavioral Associates
  • Carolina Partners in Mental HealthCare
  • Detweiler Family Medicine
  • Relaro Medical Trials
  • Tidewater Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IDgenetix Neuropsychiatric Test Panel Intervention

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2016
Last Updated
December 16, 2016
Sponsor
AltheaDx
Collaborators
Innovis LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02878928
Brief Title
Clinical Study Evaluating Effects of Pharmacogenetic-guided vs Standard-of-Care Treatment on Depression and/or Anxiety
Official Title
A Prospective, Multi-Center, Randomized Clinical Study to Evaluate the Clinical Impact of Pharmacogenetic-Guided Treatment for Depression & Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AltheaDx
Collaborators
Innovis LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Pharmacogenetic testing, PGx, Depression, Neuropsychiatric diseases, IDgenetix, AltheaDx

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
579 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDgenetix Neuropsychiatric Test Panel Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Genetic
Intervention Name(s)
IDgenetix Neuropsychiatric Test Panel
Other Intervention Name(s)
PGx Testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in the Hamilton Rating Scale for Depression (HAMD-17) score from baseline.
Time Frame
12 weeks
Title
Change in the Hamilton Rating Scale for Anxiety (HAM-A) score from baseline.
Time Frame
12 weeks
Title
Percentage of depression subjects who respond (≥50% decrease in HAM-D17 from baseline or remit, HAM-D17 total score ≤7).
Time Frame
12 weeks
Title
Percentage of anxiety subjects who respond (≥50% decrease in HAM-A from baseline or remit, HAM-A total score ≤7)
Time Frame
12 weeks
Title
Time to response/remission of depressive symptoms.
Time Frame
12 weeks
Title
Time to response/remission of anxiety symptoms.
Time Frame
12 weeks
Title
Medication change: Number of subjects who changed their antidepressant and anxiety medication regimens from baseline.
Time Frame
12 weeks
Title
The impact of pharmacogenetic-guided treatment.care costs as measured by HMWDQ
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Centeno
Organizational Affiliation
AltheaDx
Official's Role
Study Director
Facility Information:
Facility Name
Adnab Research
City
Rolling Hills
State/Province
California
Country
United States
Facility Name
Artemis Clinical Research
City
San Diego
State/Province
California
Country
United States
Facility Name
Adnab Research
City
Torrance
State/Province
California
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Torrance
State/Province
California
Country
United States
Facility Name
Innovative Clinical Research
City
Lauderhill
State/Province
Florida
Country
United States
Facility Name
Innova Clinical Trials
City
Miami
State/Province
Florida
Country
United States
Facility Name
APG Research
City
Orlando
State/Province
Florida
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Medpharmics
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Meridian Clinical Research
City
Norfolk
State/Province
Nebraska
Country
United States
Facility Name
United Medical Associates
City
Binghamton
State/Province
New York
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Carolina Partners in Mental HealthCare
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Detweiler Family Medicine
City
Lansdale
State/Province
Pennsylvania
Country
United States
Facility Name
Relaro Medical Trials
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Tidewater Clinical Research
City
Virginia Beach
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28992526
Citation
Bradley P, Shiekh M, Mehra V, Vrbicky K, Layle S, Olson MC, Maciel A, Cullors A, Garces JA, Lukowiak AA. Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility. J Psychiatr Res. 2018 Jan;96:100-107. doi: 10.1016/j.jpsychires.2017.09.024. Epub 2017 Sep 23.
Results Reference
derived

Learn more about this trial

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

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