Antidepressants Causing Adverse Effects in Therapeutic Use Clinical Trial
Official title:
Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care
Verified date | March 2023 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | May 6, 2022 |
Est. primary completion date | September 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Physician participants Inclusion criteria: - 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 Exclusion criteria: -Do not meet inclusion criteria Patient Participants Inclusion: - 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 Exclusion: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acceptability of PGx Testing | Acceptability of PGx testing in primary care among persons taking a target antidepressant and primary care physicians who care for them | Baseline and 6 months | |
Primary | Count of Participants Prescribed Antidepressant Medication | Count of participants who have been prescribed antidepressant medications which are not contraindicated | Baseline, 3 months, 6 months, and 9 months | |
Secondary | 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. | Baseline and 6 months | |
Secondary | 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. | Baseline and 6 months | |
Secondary | 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. |
Baseline and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05628467 -
Association Between Antidepressant Use and Falls in Older Adults: Analysis of the World Health Organization Global Database
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