Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02878928
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : December 19, 2016
Innovis LLC
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Genetic: IDgenetix Neuropsychiatric Test Panel Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Prospective, Multi-Center, Randomized Clinical Study to Evaluate the Clinical Impact of Pharmacogenetic-Guided Treatment for Depression & Anxiety
Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02878928

Layout table for location information
United States, California
Adnab Research
Rolling Hills, California, United States
Artemis Clinical Research
San Diego, California, United States
Adnab Research
Torrance, California, United States
Collaborative Neuroscience Network
Torrance, California, United States
United States, Florida
Innovative Clinical Research
Lauderhill, Florida, United States
Innova Clinical Trials
Miami, Florida, United States
APG Research
Orlando, Florida, United States
United States, Georgia
iResearch Atlanta
Decatur, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
United States, Louisiana
Metairie, Louisiana, United States
United States, Nebraska
Meridian Clinical Research
Norfolk, Nebraska, United States
United States, New York
United Medical Associates
Binghamton, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
United States, North Carolina
Carolina Partners in Mental HealthCare
Raleigh, North Carolina, United States
United States, Pennsylvania
Detweiler Family Medicine
Lansdale, Pennsylvania, United States
United States, Texas
Relaro Medical Trials
Dallas, Texas, United States
United States, Virginia
Tidewater Clinical Research
Virginia Beach, Virginia, United States
Sponsors and Collaborators
Innovis LLC
Layout table for investigator information
Study Director: Joel Centeno AltheaDx

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AltheaDx Identifier: NCT02878928     History of Changes
Other Study ID Numbers: CLP-0009
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AltheaDx:
Pharmacogenetic testing
Neuropsychiatric diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders