DepressionNCT02411123
Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders
A study testing IDgenetix Neuropsychiatric Test Panel in people with Depression and Anxiety, run by AltheaDx at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as depression and anxiety, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between the ages of 18 and 80
- Experiencing or showing evidence of a neuropsychiatric disorder (depression, anxiety, attention deficit hyperactivity disorder and psychosis) as determined by a qualified clinician
- Subjects new to the medical provider
- 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 subject for whom providing a buccal swab sample would be contraindicated or not possible
- Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5)
- Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5x normal, or suspected cirrhosis
- History of malabsorption (short gut syndrome)
- Any gastric or small bowel surgery less than 3 months prior to study enrollment
- Subject is being treated with intravenous medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Partners in Mental HealthCare
Raleigh, North Carolina, 27609
About this study
Official title: Prospective Randomized Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as depression and anxiety, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their treatment.
This study will also evaluate whether pharmacogenetic (PGx) testing can reduce adverse drug events, hospitalization rates, hospital length of stay, emergency room visits, disability, death or other serious drug side effects.
Read the detailed description
Anti-depressant and anti-anxiety medications are still administered by a trial and error method, which results in a substantial number of patients suffering from either a lack of benefit from drug therapy or severe side effects. Approximately 40% of all anti-depressant and anti-anxiety medications prescribed are ineffective, and patients who need to be on medication often discontinue taking their medications, which can have potentially dangerous consequences. 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 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.
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, randomized, single-blind study, new patients presenting to the clinical site with evidence of depression 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 4-month duration of the study.
- Conditions
- Depression, Anxiety
- Being tested
- IDgenetix Neuropsychiatric Test Panel
- Keywords
- PGx, pharmacogenetics, depression, anxiety, 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 | The medical provider for the 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 | No intervention | The medical provider 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.
Comparison of change in neuropsychiatric state between the two treatment arms measured by Neuropsychiatric Questionnaire (NPQ)
Neuropsychiatric Questionnaire (NPQ) score change comparison between the two treatment arms over a 4-month period.
Measured: 4 months
Comparison of change in responsiveness between the two treatment arms measured by Symbol Digit Coding (SDC) test
Symbol Digit Coding (SDC) test score change comparison between the two treatment arms over a 4-month period.
Measured: 4 months
Secondary outcomes (2)
Comparison of hospital utilization between the two treatment arms as measured by hospital admission and re-admission rates
Comparison of hospital utilization, as measured by hospital admission and re-admission rates, between the two treatment arms over a 4-month period.
Measured: 4 months
Comparison of adverse drug events between the two treatment arms over a 4-month period
Comparison of adverse drug events between the two treatment arms over a 4-month period
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AltheaDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carolina Partners in Mental Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411123
- Sponsor's protocol ID
- CLP0002
- Status last verified
- Dec 2015
- First submitted
- 1 Apr 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Masand PS. Tolerability and adherence issues in antidepressant therapy. Clin Ther. 2003 Aug;25(8):2289-304. doi: 10.1016/s0149-2918(03)80220-5.
PubMed 14512135Crisafulli C, Fabbri C, Porcelli S, Drago A, Spina E, De Ronchi D, Serretti A. Pharmacogenetics of antidepressants. Front Pharmacol. 2011 Feb 16;2:6. doi: 10.3389/fphar.2011.00006. eCollection 2011.
PubMed 21687501Mrazek DA. Psychiatric pharmacogenomic testing in clinical practice. Dialogues Clin Neurosci. 2010;12(1):69-76. doi: 10.31887/DCNS.2010.12.1/dmrazek.
PubMed 20373668Serretti A, Kato M, De Ronchi D, Kinoshita T. Meta-analysis of serotonin transporter gene promoter polymorphism (5-HTTLPR) association with selective serotonin reuptake inhibitor efficacy in depressed patients. Mol Psychiatry. 2007 Mar;12(3):247-57. doi: 10.1038/sj.mp.4001926. Epub 2006 Dec 5.
PubMed 17146470Olson MC, Maciel A, Gariepy JF, Cullors A, Saldivar JS, Taylor D, Centeno J, Garces JA, Vaishnavi S. Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial. Prim Care Companion CNS Disord. 2017 Mar 16;19(2). doi: 10.4088/PCC.16m02036.
PubMed 28314093
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders
- ClinicalTrials.gov ID
- NCT02411123
- Acronym / sponsor ID
- CLP0002
- Conditions
- Depression, Anxiety
- Keywords
- PGx, pharmacogenetics, depression, anxiety, Neuropsychiatric diseases, IDgenetix, AltheaDx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- AltheaDxIndustry (pharma, biotech, devices)
- Collaborators
- Carolina Partners in Mental Healthcare
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Apr 2015 (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.
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as depression and anxiety, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their treatment.
This study will also evaluate whether pharmacogenetic (PGx) testing can reduce adverse drug events, hospitalization rates, hospital length of stay, emergency room visits, disability, death or other serious drug side effects.
Detailed description
Anti-depressant and anti-anxiety medications are still administered by a trial and error method, which results in a substantial number of patients suffering from either a lack of benefit from drug therapy or severe side effects. Approximately 40% of all anti-depressant and anti-anxiety medications prescribed are ineffective, and patients who need to be on medication often discontinue taking their medications, which can have potentially dangerous consequences. 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 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.
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, randomized, single-blind study, new patients presenting to the clinical site with evidence of depression 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 4-month duration of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDgenetix Neuropsychiatric Test Panel Intervention | Experimental | Genetic: IDgenetix Neuropsychiatric Test PanelThe medical provider for the 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 | No intervention | –The medical provider 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 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects between the ages of 18 and 80
- Experiencing or showing evidence of a neuropsychiatric disorder (depression, anxiety, attention deficit hyperactivity disorder and psychosis) as determined by a qualified clinician
- Subjects new to the medical provider
- Willing and able to comply with study procedures
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Unwilling or unable to provide written informed consent and to comply with study procedures
- Any subject for whom providing a buccal swab sample would be contraindicated or not possible
- Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5)
- Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5x normal, or suspected cirrhosis
- History of malabsorption (short gut syndrome)
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
Comparison of change in neuropsychiatric state between the two treatment arms measured by Neuropsychiatric Questionnaire (NPQ)
Time frame: 4 months
Neuropsychiatric Questionnaire (NPQ) score change comparison between the two treatment arms over a 4-month period.
Comparison of change in responsiveness between the two treatment arms measured by Symbol Digit Coding (SDC) test
Time frame: 4 months
Symbol Digit Coding (SDC) test score change comparison between the two treatment arms over a 4-month period.
2 secondary outcomes
Comparison of hospital utilization between the two treatment arms as measured by hospital admission and re-admission rates
Time frame: 4 months
Comparison of adverse drug events between the two treatment arms over a 4-month period
Time frame: 4 months
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 29 Dec 2015.
- Background: PubMed 14512135Masand PS. Tolerability and adherence issues in antidepressant therapy. Clin Ther. 2003 Aug;25(8):2289-304. doi: 10.1016/s0149-2918(03)80220-5.
- Background: PubMed 21687501Crisafulli C, Fabbri C, Porcelli S, Drago A, Spina E, De Ronchi D, Serretti A. Pharmacogenetics of antidepressants. Front Pharmacol. 2011 Feb 16;2:6. doi: 10.3389/fphar.2011.00006. eCollection 2011.
- Background: PubMed 20373668Mrazek DA. Psychiatric pharmacogenomic testing in clinical practice. Dialogues Clin Neurosci. 2010;12(1):69-76. doi: 10.31887/DCNS.2010.12.1/dmrazek.
- Background: PubMed 17146470Serretti A, Kato M, De Ronchi D, Kinoshita T. Meta-analysis of serotonin transporter gene promoter polymorphism (5-HTTLPR) association with selective serotonin reuptake inhibitor efficacy in depressed patients. Mol Psychiatry. 2007 Mar;12(3):247-57. doi: 10.1038/sj.mp.4001926. Epub 2006 Dec 5.
- Derived from this study: PubMed 28314093Olson MC, Maciel A, Gariepy JF, Cullors A, Saldivar JS, Taylor D, Centeno J, Garces JA, Vaishnavi S. Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial. Prim Care Companion CNS Disord. 2017 Mar 16;19(2). doi: 10.4088/PCC.16m02036.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1 site 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 5 inclusion and 7 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Comparison of change in neuropsychiatric state between the two treatment arms measured by Neuropsychiatric Questionnaire (NPQ) (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT02411123, which also lists 5 linked publications.
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 29 Dec 2015.