Clinical Study Evaluating Effects of Pharmacogenetic-guided vs Standard-of-Care Treatment on Depression and/or Anxiety
NCT ID: NCT02878928
Last Updated: 2016-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
579 participants
INTERVENTIONAL
2016-05-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Innovis LLC
INDUSTRY
AltheaDx
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Centeno
Role: STUDY_DIRECTOR
AltheaDx
Locations
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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
Innovative Clinical Research
Lauderhill, Florida, United States
Innova Clinical Trials
Miami, Florida, United States
APG Research
Orlando, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Medpharmics
Metairie, Louisiana, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
United Medical Associates
Binghamton, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Carolina Partners in Mental HealthCare
Raleigh, North Carolina, United States
Detweiler Family Medicine
Lansdale, Pennsylvania, United States
Relaro Medical Trials
Dallas, Texas, United States
Tidewater Clinical Research
Virginia Beach, Virginia, United States
Countries
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References
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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.
Other Identifiers
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CLP-0009
Identifier Type: -
Identifier Source: org_study_id