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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Change in the Hamilton Rating Scale for Depression (HAMD-17) score from baseline.
Measured: 12 weeks
Change in the Hamilton Rating Scale for Anxiety (HAM-A) score from baseline.
Measured: 12 weeks
Percentage of depression subjects who respond (≥50% decrease in HAM-D17 from baseline or remit, HAM-D17 total score ≤7).
Measured: 12 weeks
Percentage of anxiety subjects who respond (≥50% decrease in HAM-A from baseline or remit, HAM-A total score ≤7)
Measured: 12 weeks
Time to response/remission of depressive symptoms.
Measured: 12 weeks
Time to response/remission of anxiety symptoms.
Measured: 12 weeks
Medication change: Number of subjects who changed their antidepressant and anxiety medication regimens from baseline.
Measured: 12 weeks
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.
- First posted25 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AltheaDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovis LLC
- Responsible party
- Sponsor
- Investigators
- Joel Centeno, Study director, AltheaDx
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized Clinical Study to Evaluate the Clinical Impact of Pharmacogenetic-Guided Treatment for Depression & Anxiety
- ClinicalTrials.gov ID
- NCT02878928
- Acronym / sponsor ID
- CLP-0009
- Conditions
- Depression, Anxiety
- Keywords
- Pharmacogenetic testing, PGx, Depression, Neuropsychiatric diseases, IDgenetix, AltheaDx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- AltheaDxIndustry (pharma, biotech, devices)
- Collaborators
- Innovis LLC
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDgenetix Neuropsychiatric Test Panel Intervention | Experimental | Genetic: IDgenetix Neuropsychiatric Test PanelMedical 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Willing and able to comply with study procedures.
- Able to provide written informed consent.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDgenetix Neuropsychiatric Test PanelAlso: PGx TestingThe IDgenetix Neuropsychiatric Test Panel is used to make recommendations on the medication therapy that might be impacted by the genetic background of the patient. | Genetic | IDgenetix Neuropsychiatric Test Panel Intervention |
Primary outcome
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
8 secondary outcomes
Change in the Hamilton Rating Scale for Depression (HAMD-17) score from baseline.
Time frame: 12 weeks
Change in the Hamilton Rating Scale for Anxiety (HAM-A) score from baseline.
Time frame: 12 weeks
Percentage of depression subjects who respond (≥50% decrease in HAM-D17 from baseline or remit, HAM-D17 total score ≤7).
Time frame: 12 weeks
Percentage of anxiety subjects who respond (≥50% decrease in HAM-A from baseline or remit, HAM-A total score ≤7)
Time frame: 12 weeks
Time to response/remission of depressive symptoms.
Time frame: 12 weeks
Time to response/remission of anxiety symptoms.
Time frame: 12 weeks
Medication change: Number of subjects who changed their antidepressant and anxiety medication regimens from baseline.
Time frame: 12 weeks
The impact of pharmacogenetic-guided treatment.care costs as measured by HMWDQ
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Derived from this study: PubMed 28992526Bradley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Centeno study director
AltheaDx
17 sites in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 6 Nov 2026.