Antidepressants Causing Adverse Effects in Therapeutic UseNCT03270891
Pharmacogenomic Testing in Primary Care
A study testing PGx test in people with Antidepressants Causing Adverse Effects in Therapeutic Use, run by University of Michigan at 1 site in United States.
Trial summary
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results to manage antidepressant use will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antidepressants Causing Adverse Effects in Therapeutic Use
- What is being tested?
- PGx test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 6 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be a practicing physician at a University of Michigan Department of Family Medicine clinic
- Be willing to use PGx test results for their patients enrolled in the study
- Be willing to allow study staff to contact their patients
- Self-report that they are willing to prescribe antidepressants
- Be a patient of a participating physician
- Have a new prescription for one of the following antidepressant medications: citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Prozac Weekly, Rapiflux, Sarafem, Selfemra), fluvoxamine (Luvox, Luvox CR), paroxetine (Paxil, Paxil CR), sertraline (Zoloft), duloxetine (Cymbalta, Irenka), venlafaxine (Effexor), venlafaxine XR (Effexor XR), nortriptyline (Aventyl, Pamelor), bupropion (Forfivo XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL), mirtazapine (Remeron, Remeron Soltab), or vortioxetine (Trintellix)
- Be willing to undergo PGx testing via single tube blood draw
Who cannot join
- -Do not meet inclusion criteria
- Patient Participants
- Do not speak English
- Have previously undergone PGx testing
- Are unable to provide their own consent to participate in the study
- Have been taking the new antidepressant prescription for longer than 4 weeks (prior to screening)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results to manage antidepressant use will be enrolled. Patients of these DFM physicians who are adults with a new prescription for a target antidepressant will also be enrolled.
Read the detailed description
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). We will enroll physicians practicing at a UM DFM clinical site who are willing to utilize PGx test results in conjunction with treating patients prescribed certain antidepressants. We will also enroll patients of these DFM physicians who are adults with a new prescription for an antidepressant (within the past 4 weeks) including patients who have switched to a new antidepressant from another antidepressant or have added on a new antidepressant to current antidepressant therapy. Patients are excluded if taking an antidepressant for more than 4 weeks or if they have had PGx testing in the past. Patients will be randomized to either an intervention or control group. Patients in the intervention group will have PGx test results available soon after enrollment while the control patients will have test results available 3 months after the first visit. All patients will complete a baseline, 3-, and 6-month assessment; control patients will have an additional 9-month assessment. Data to be collected include symptoms and severity (PHQ-8, GAD7), functional health status (SF-12), PGx knowledge, work status changes, demographic information, physician and emergency department visits, adverse effects, and medication alterations and adherence.
- Being tested
- PGx test
- Keywords
- Pharmacogenomics, Primary care physicians
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGx testDiagnostic test
Also called Pharmacogenomic test, Progenity Informed PGx test
A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.
| Study group | Role | What they receive |
|---|---|---|
| Delayed intervention (control arm) | Active comparator | Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment Receives: Diagnostic Test: PGx test |
| PGx Test | Experimental | Patients in this arm will have PGx test results made available to physicians as soon available after enrollment. Receives: Diagnostic Test: PGx test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants Prescribed Antidepressant Medication
Count of participants who have been prescribed antidepressant medications which are not contraindicated
Measured: Baseline, 3 months, 6 months, and 9 months
Secondary outcomes (3)
Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)
Change in PHQ-8 scores. The PHQ-8 is an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.
Measured: Baseline and 6 months
Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)
The GAD-7 is a self-administered assessment for general anxiety disorder. The total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome.
Measured: Baseline and 6 months
Change in Adherence to Refills and Medication Scale (ARMS) Scores
Change in medication adherence: The Adherence to Refills and Medication was scored by summing together the 14 items after first reversing the final item to be consistent in direction with the others. Individuals were allowed to have up to 2 missing values present which were imputed with the mean of the remaining answered items, only a handful of individuals answered 13 of the 14 questions resulting in a single item within their scale being imputed across the time periods.
The questionnaire has 14 items with each item being recorded on a four-point Likert scale. The total score ranges from 14-56 with the lower score indicating better adherence.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Dec 2017
- Primary completion5 Sep 2021
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antidepressants Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorraine Buis, University of Michigan
- Investigators
- Lorriane Buis, PhD, Principal investigator, University of Michigan Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270891
- Sponsor's protocol ID
- HUM00121185
- Status last verified
- Mar 2023
- First submitted
- 28 Aug 2017
- Last updated
- 11 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Manzor Mitrzyk B, Kadri R, Farris KB, Ellingrod VL, Klinkman MS, Ruffin Iv MT, Plegue MA, Buis LR. Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study. JMIR Res Protoc. 2019 Aug 19;8(8):e13848. doi: 10.2196/13848.
PubMed 31429417
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care
- ClinicalTrials.gov ID
- NCT03270891
- Acronym / sponsor ID
- HUM00121185
- Keywords
- Pharmacogenomics, Primary care physicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Posted 11 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results to manage antidepressant use will be enrolled. Patients of these DFM physicians who are adults with a new prescription for a target antidepressant will also be enrolled.
Detailed description
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). We will enroll physicians practicing at a UM DFM clinical site who are willing to utilize PGx test results in conjunction with treating patients prescribed certain antidepressants. We will also enroll patients of these DFM physicians who are adults with a new prescription for an antidepressant (within the past 4 weeks) including patients who have switched to a new antidepressant from another antidepressant or have added on a new antidepressant to current antidepressant therapy. Patients are excluded if taking an antidepressant for more than 4 weeks or if they have had PGx testing in the past. Patients will be randomized to either an intervention or control group. Patients in the intervention group will have PGx test results available soon after enrollment while the control patients will have test results available 3 months after the first visit. All patients will complete a baseline, 3-, and 6-month assessment; control patients will have an additional 9-month assessment. Data to be collected include symptoms and severity (PHQ-8, GAD7), functional health status (SF-12), PGx knowledge, work status changes, demographic information, physician and emergency department visits, adverse effects, and medication alterations and adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed intervention (control arm) | Active comparator | Diagnostic Test: PGx testPatients in this arm will have PGx test results made available to physicians 3 months after study enrollment |
| PGx Test | Experimental | Diagnostic Test: PGx testPatients in this arm will have PGx test results made available to physicians as soon available after enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be a practicing physician at a University of Michigan Department of Family Medicine clinic
- Be willing to use PGx test results for their patients enrolled in the study
- Be willing to allow study staff to contact their patients
- Self-report that they are willing to prescribe antidepressants
- Be a patient of a participating physician
Key exclusion criteria (6 listed)
- -Do not meet inclusion criteria
- Patient Participants
- Do not speak English
- Have previously undergone PGx testing
- Are unable to provide their own consent to participate in the study
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 |
|---|---|---|
| PGx testAlso: Pharmacogenomic test, Progenity Informed PGx testA laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs. | Diagnostic test | Delayed intervention (control arm), PGx Test |
Primary outcome
Count of Participants Prescribed Antidepressant Medication
Time frame: Baseline, 3 months, 6 months, and 9 months
Count of participants who have been prescribed antidepressant medications which are not contraindicated
3 secondary outcomes
Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)
Time frame: Baseline and 6 months
Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)
Time frame: Baseline and 6 months
Change in Adherence to Refills and Medication Scale (ARMS) Scores
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31429417Manzor Mitrzyk B, Kadri R, Farris KB, Ellingrod VL, Klinkman MS, Ruffin Iv MT, Plegue MA, Buis LR. Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study. JMIR Res Protoc. 2019 Aug 19;8(8):e13848. doi: 10.2196/13848.
- Individual participant dataSharing planned: No
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.
Lorriane Buis, PhD principal investigator
University of Michigan Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PGx test in people with Antidepressants Causing Adverse Effects in Therapeutic Use, run by University of Michigan 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 7 inclusion and 6 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 11 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count of Participants Prescribed Antidepressant Medication (time frame: Baseline, 3 months, 6 months, and 9 months). 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 NCT03270891, 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 11 Apr 2023.