An interventional study of PGx test in Antidepressants Causing Adverse Effects in Therapeutic Use, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
Physician participants
Inclusion criteria:
Exclusion criteria:
-Do not meet inclusion criteria
Patient Participants
Inclusion:
Exclusion:
Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
Diagnostic Test: PGx test
Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
Diagnostic Test: 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.
Also known as: Pharmacogenomic test, Progenity Informed PGx test
Count of Participants Prescribed Antidepressant Medication
Count of participants who have been prescribed antidepressant medications which are not contraindicated
Time frame: Baseline, 3 months, 6 months, and 9 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months
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
Time frame: Baseline and 6 months
| Milestone | Delayed Intervention (Control Arm) | PGx Test | Physicians |
|---|---|---|---|
| Started | 26 | 25 | 24 |
| Received intervention | 25 | 25 | 0 |
| For physician arm only; those physicians who had patients who participated | 0 | 0 | 17 |
| Completed | 22 | 19 | 17 |
| Not completed | 4 | 6 | 7 |
| Withdrew: Lost to follow-up | 3 | 6 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: For physician arm only; those physicians who did not have patients who participated | 0 | 0 | 7 |
Count of participants who have been prescribed antidepressant medications which are not contraindicated
| Participants | Delayed Intervention (Control Arm) | PGx Test |
|---|---|---|
| Baseline | 5 | 8 |
| Month 3 | 5 | 8 |
| Month 6 | 6 | 8 |
| Month 9 | 5 | — |
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.
| score on a scale | Delayed Intervention (Control Arm) | PGx Test |
|---|---|---|
| Baseline | 9.0 ± 4.4 | 8.6 ± 6.1 |
| 6 month | 7.5 ± 4.3 | 5.8 ± 5.4 |
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.
| score on a scale | Delayed Intervention (Control Arm) | PGx Test |
|---|---|---|
| baseline | 9.1 ± 6.2 | 6.9 ± 5.6 |
| Month 6 | 6.1 ± 5.0 | 5.2 ± 4.9 |
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.
| score on a scale | Delayed Intervention (Control Arm) | PGx Test |
|---|---|---|
| baseline | 17.1 ± 3.3 | 17.4 ± 3.2 |
| 6 month | 17 ± 2.5 | 16.6 ± 3.2 |
Acceptability of PGx testing in primary care among persons taking a target antidepressant and primary care physicians who care for them
Results for this outcome have not been posted.
Collected over six months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Delayed Intervention (Control Arm) | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| PGx Test | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
1 participant was withdrawn by the study staff and PI after baseline data was collected but before receiving the intervention.
| Age, Continuous(years) | Delayed Intervention (Control Arm) | PGx Test | Physicians | Total |
|---|---|---|---|---|
| Mean | 39.2 ± 13.2 | 42.0 ± 14.6 | — | 40.5 ± 13.9 |
| Sex/Gender, Customized(Participants) | Delayed Intervention (Control Arm) | PGx Test | Physicians | Total |
|---|---|---|---|---|
| Male | 13 | 10 | 8 | 31 |
| Female | 13 | 14 | 16 | 43 |
| Other | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Delayed Intervention (Control Arm) | PGx Test | Physicians | Total |
|---|---|---|---|---|
| White | 23 | 19 | 19 | 61 |
| Black | 1 | 1 | 0 | 2 |
| Asian | 1 | 1 | 3 | 5 |
| Other | 0 | 2 | 2 | 4 |
| Unknown | 1 | 2 | 0 | 3 |
| Region of Enrollment(Participants) | Delayed Intervention (Control Arm) | PGx Test | Physicians | Total |
|---|---|---|---|---|
| United States | 26 | 25 | 24 | 75 |
| Marital Status(Participants) | Delayed Intervention (Control Arm) | PGx Test | Physicians | Total |
|---|---|---|---|---|
| Not Married | 15 | 10 | — | 25 |
| Married | 11 | 15 | — | 26 |
| Education(Participants) | Delayed Intervention (Control Arm) | PGx Test | Physicians | Total |
|---|---|---|---|---|
| <4 yrs College | 8 | 11 | 0 | 19 |
| Bachelor's Degree | 7 | 6 | 0 | 13 |
| Graduate | 11 | 8 | 24 | 43 |
| Employment(Participants) | Delayed Intervention (Control Arm) | PGx Test | Physicians | Total |
|---|---|---|---|---|
| Unemployed | 7 | 8 | 0 | 15 |
| Employed | 19 | 17 | 24 | 60 |
| Income(Participants) | Delayed Intervention (Control Arm) | PGx Test | Physicians | Total |
|---|---|---|---|---|
| <50k | 7 | 8 | — | 15 |
| 50k-99k | 10 | 7 | — | 17 |
| 100k+ | 9 | 10 | — | 19 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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