PharmacogeneticsNCT04893395
Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
A study testing Pharmacogenomic Screening in people with Pharmacogenetics and Depressive Disorder, Major, run by Auburn University at 1 site in United States.
Trial summary
The purpose of this study is to assess the prevalence of veterans with major depressive disorder (MDD) who are being treated with a medication that has current Clinical Pharmacogenetics Implementation Consortium (CPIC) or Pharmacogenomics Knowledgebase (PharmGKB) actionable recommendations that have a pharmacogenomic… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pharmacogenetics, Depressive Disorder, Major, Medication Therapy Management
- What is being tested?
- Pharmacogenomic Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Prescribed at least one chronic medication for mental health which is considered pharmacogenomically actionable, as defined above (amitriptyline, doxepin, imipramine, nortriptyline, citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, or venlafaxine).
- Diagnosis of major depressive disorder (MDD)
Who cannot join
- Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration
- Persistent medication non-adherence for reasons not potentially linked to pharmacogenomic variation (e.g. inability to obtain medications due to cost; non-adherence due to cognitive impairment)
- Individuals receiving mental health treatment/care from a non-VA facility
- Individuals who are terminally ill
- Inability to communicate in and/or understand English
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the prevalence of veterans with major depressive disorder (MDD) who are being treated with a medication that has current Clinical Pharmacogenetics Implementation Consortium (CPIC) or Pharmacogenomics Knowledgebase (PharmGKB) actionable recommendations that have a pharmacogenomic variation that impacts the safety or efficacy of the subject medication.
- Being tested
- Pharmacogenomic Screening
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic ScreeningOther
First telehealth appointment:
- Pharmacogenomics education and informed consent
- Medical history
- Sample collection
Second telehealth appointment:
- Results of pharmacogenomic testing
- Utility and limitations of pharmacogenomic testing
- Patient-specific potential impacts on current or future medication therapies
- Answering of patient questions
- Referral to mental health provider(s) for treatment-specific recommendations
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenomic Screening | Experimental | Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits. Receives: Other: Pharmacogenomic Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized
A medication history will be conducted at enrollment to ensure patient meets criteria for enrollment. Patients will provide a saliva sample at this timepoint. The rate of pharmacogenomic variation will be calculated based on current medications at enrollment; however, the pharmacogenomic screening panel may take up to 6 weeks to return to the patient and investigator.
Measured: At enrollment
Secondary outcomes (11)
Rate of pharmacogenomic variation with actionable recommendations for all actionable medications
Measured: At enrollment
Mental health disease state control/progression utilizing disease state-specific validated tools
Validated, disease state-specific tools will be utilized to assess control or progression. Specifically, depression control will be assessed utilizing PHQ-9 as documented within the chart. This will be assessed via retrospective chart review.
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Medication-related costs
Claims data will be used to assess medication-related costs at specific time points.
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Medication-related adverse events
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Patient reported medication adherence and reasons for non-adherence
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Patient reported reasons for non-adherence
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Number of pharmacogenomic recommendations made and accepted
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Type of pharmacogenomic recommendations made and accepted
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Number of non-pharmacogenomic recommendations made and accepted
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Type of non-pharmacogenomic recommendations made and accepted
Measured: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Does not meet criteria for a clinical trial per IRB review.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacogeneticsStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Tuscaloosa Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Courtney Watts Alexander, Auburn University
- Investigators
- Kimberly B Lloyd, Pharm.D., Study director, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893395
- Sponsor's protocol ID
- TVA_IRBNetID_1614352
- Status last verified
- Aug 2022
- First submitted
- 12 May 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
- ClinicalTrials.gov ID
- NCT04893395
- Acronym / sponsor ID
- TVA_IRBNetID_1614352
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Does not meet criteria for a clinical trial per IRB review.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Tuscaloosa Veterans Affairs Medical Center
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 May 2021 (actual)
- 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 assess the prevalence of veterans with major depressive disorder (MDD) who are being treated with a medication that has current Clinical Pharmacogenetics Implementation Consortium (CPIC) or Pharmacogenomics Knowledgebase (PharmGKB) actionable recommendations that have a pharmacogenomic variation that impacts the safety or efficacy of the subject medication.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenomic Screening | Experimental | Other: Pharmacogenomic ScreeningEligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 19 years
- Prescribed at least one chronic medication for mental health which is considered pharmacogenomically actionable, as defined above (amitriptyline, doxepin, imipramine, nortriptyline, citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, or venlafaxine).
- Diagnosis of major depressive disorder (MDD)
Key exclusion criteria (5 listed)
- Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration
- Persistent medication non-adherence for reasons not potentially linked to pharmacogenomic variation (e.g. inability to obtain medications due to cost; non-adherence due to cognitive impairment)
- Individuals receiving mental health treatment/care from a non-VA facility
- Individuals who are terminally ill
- Inability to communicate in and/or understand English
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 |
|---|---|---|
| Pharmacogenomic ScreeningFirst telehealth appointment: 1. Pharmacogenomics education and informed consent 2. Medical history 3. Sample collection Second telehealth appointment: 1. Results of pharmacogenomic testing 2. Utility and limitations of pharmacogenomic testing 3. Patient-specific potential impacts on current or future medication therapies 4. Answering of patient questions 5. Referral to mental health provider(s) for treatment-specific recommendations | Other | Pharmacogenomic Screening |
Primary outcome
Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized
Time frame: At enrollment
A medication history will be conducted at enrollment to ensure patient meets criteria for enrollment. Patients will provide a saliva sample at this timepoint. The rate of pharmacogenomic variation will be calculated based on current medications at enrollment; however, the pharmacogenomic screening panel may take up to 6 weeks to return to the patient and investigator.
11 secondary outcomes
Rate of pharmacogenomic variation with actionable recommendations for all actionable medications
Time frame: At enrollment
Mental health disease state control/progression utilizing disease state-specific validated tools
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Medication-related costs
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Medication-related adverse events
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Patient reported medication adherence and reasons for non-adherence
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Patient reported reasons for non-adherence
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Number of pharmacogenomic recommendations made and accepted
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Type of pharmacogenomic recommendations made and accepted
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Number of non-pharmacogenomic recommendations made and accepted
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Type of non-pharmacogenomic recommendations made and accepted
Time frame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- 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.
Kimberly B Lloyd, Pharm.D. study director
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomic Screening in people with Pharmacogenetics and Depressive Disorder, Major, run by Auburn University 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 9 Aug 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.