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

NCT02878928 | Completed

• 1 other identifier: CLP-0009
• Study Type: interventional
• Target: 579
• Locations: 1 country
• Sites: 17

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.

Conditions

Depression; Anxiety

Keywords

Pharmacogenetic testing; PGx; Depression; Neuropsychiatric diseases; IDgenetix; AltheaDx

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (8)

• Change in the Hamilton Rating Scale for Depression (HAMD-17) score from baseline.

  12 weeks

• Change in the Hamilton Rating Scale for Anxiety (HAM-A) score from baseline.

  12 weeks

• Percentage of depression subjects who respond (≥50% decrease in HAM-D17 from baseline or remit, HAM-D17 total score ≤7).

  12 weeks

• Percentage of anxiety subjects who respond (≥50% decrease in HAM-A from baseline or remit, HAM-A total score ≤7)

  12 weeks

• Time to response/remission of depressive symptoms.

  12 weeks

Study Arms (2)

IDgenetix Neuropsychiatric Test Panel Intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AltheaDx: lead
• Innovis LLC: collaborator

Study Sites (17)

Adnab Research

Rolling Hills, California, United States

Location

Artemis Clinical Research

San Diego, California, United States

Location

Adnab Research

Torrance, California, United States

Location

Collaborative Neuroscience Network

Torrance, California, United States

Location

Innovative Clinical Research

Lauderhill, Florida, United States

Location

Innova Clinical Trials

Miami, Florida, United States

Location

APG Research

Orlando, Florida, United States

Location

iResearch Atlanta

Decatur, Georgia, United States

Location

Meridian Clinical Research

Savannah, Georgia, United States

Location

Medpharmics

Metairie, Louisiana, United States

Location

Meridian Clinical Research

Norfolk, Nebraska, United States

Location

United Medical Associates

Binghamton, New York, United States

Location

Richmond Behavioral Associates

Staten Island, New York, United States

Location

Carolina Partners in Mental HealthCare

Raleigh, North Carolina, United States

Location

Detweiler Family Medicine

Lansdale, Pennsylvania, United States

Location

Relaro Medical Trials

Dallas, Texas, United States

Location

Tidewater Clinical Research

Virginia Beach, Virginia, United States

Location

Related Publications (1)

• 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.

  PMID: 28992526 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Joel Centeno

  AltheaDx

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: August 25, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)