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DepressionNCT02878928

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

A study testing IDgenetix Neuropsychiatric Test Panel in people with Depression and Anxiety, run by AltheaDx at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Anxiety
What is being tested?
IDgenetix Neuropsychiatric Test Panel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
579 participants
Where
17 sitesUnited States
Study dates
May 2016to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • United Medical Associates

    Binghamton, New York

  • Relaro Medical Trials

    Dallas, Texas

  • iResearch Atlanta

    Decatur, Georgia

  • Detweiler Family Medicine

    Lansdale, Pennsylvania

  • Innovative Clinical Research

    Lauderhill, Florida

  • Medpharmics

    Metairie, Louisiana

  • Innova Clinical Trials

    Miami, Florida

  • Meridian Clinical Research

    Norfolk, Nebraska

  • APG Research

    Orlando, Florida

  • Carolina Partners in Mental HealthCare

    Raleigh, North Carolina

  • Adnab Research

    Rolling Hills, California

  • Artemis Clinical Research

    San Diego, California

  • Meridian Clinical Research

    Savannah, Georgia

  • Richmond Behavioral Associates

    Staten Island, New York

  • Adnab Research

    Torrance, California

  • Collaborative Neuroscience Network

    Torrance, California

  • Tidewater Clinical Research

    Virginia Beach, Virginia

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Depression, Anxiety
Being tested
IDgenetix Neuropsychiatric Test Panel
Keywords
Pharmacogenetic testing, PGx, Depression, Neuropsychiatric diseases, IDgenetix, AltheaDx
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDgenetix Neuropsychiatric Test PanelGenetic

    Also called PGx Testing

    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.

Study groups in NCT02878928
Study groupRoleWhat they receive
IDgenetix Neuropsychiatric Test Panel InterventionExperimentalMedical 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.
Receives: Genetic: IDgenetix Neuropsychiatric Test Panel
Control GroupNo interventionMedical 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (8)

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

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

    Measured: 12 weeks

  5. Time to response/remission of depressive symptoms.

    Measured: 12 weeks

  6. Time to response/remission of anxiety symptoms.

    Measured: 12 weeks

  7. Medication change: Number of subjects who changed their antidepressant and anxiety medication regimens from baseline.

    Measured: 12 weeks

  8. The impact of pharmacogenetic-guided treatment.care costs as measured by HMWDQ

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
579 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02878928
Sponsor's protocol ID
CLP-0009
Status last verified
Dec 2016
First submitted
14 Jul 2016
Last updated
19 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28992526

Questions about this trial

What is this clinical trial studying?

A study testing IDgenetix Neuropsychiatric Test Panel in people with Depression and Anxiety, run by AltheaDx at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02878928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.

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