Trial Outcomes & Findings for Pharmacogenomic Testing in Primary Care (NCT NCT03270891)
NCT ID: NCT03270891
Last Updated: 2023-04-11
Results Overview
Count of participants who have been prescribed antidepressant medications which are not contraindicated
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Baseline, 3 months, 6 months, and 9 months
Results posted on
2023-04-11
Participant Flow
Participant milestones
| Measure |
Delayed Intervention (Control Arm)
Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
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.
|
PGx Test
Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
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.
|
Physicians
Physicians who practiced at 1 of the 6 UM Family Medicine clinics.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
24
|
|
Overall Study
Received Intervention
|
25
|
25
|
0
|
|
Overall Study
For Physician Arm Only; Those Physicians Who Had Patients Who Participated
|
0
|
0
|
17
|
|
Overall Study
COMPLETED
|
22
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
7
|
Reasons for withdrawal
| Measure |
Delayed Intervention (Control Arm)
Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
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.
|
PGx Test
Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
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.
|
Physicians
Physicians who practiced at 1 of the 6 UM Family Medicine clinics.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
For Physician arm only; those physicians who did not have patients who participated
|
0
|
0
|
7
|
Baseline Characteristics
Protocol had no plans to collect number of children data from physicians.
Baseline characteristics by cohort
| Measure |
Delayed Intervention (Control Arm)
n=26 Participants
Participants in this arm will have PGx test results made available to physicians 3 months after study enrollment
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.
|
PGx Test
n=25 Participants
Participants in this arm will have PGx test results made available to physicians as soon available after enrollment.
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.
|
Physicians
n=24 Participants
Physicians who practiced at 1 of the 6 UM Family Medicine clinics.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Number of Children
At Least One
|
12 Participants
n=26 Participants • Protocol had no plans to collect number of children data from physicians.
|
12 Participants
n=25 Participants • Protocol had no plans to collect number of children data from physicians.
|
—
|
24 Participants
n=51 Participants • Protocol had no plans to collect number of children data from physicians.
|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 13.2 • n=26 Participants • Physician age is reported as a study specific outcome measure so that the total means are not mixed between participants and physicians.
|
42.0 years
STANDARD_DEVIATION 14.6 • n=25 Participants • Physician age is reported as a study specific outcome measure so that the total means are not mixed between participants and physicians.
|
—
|
40.5 years
STANDARD_DEVIATION 13.9 • n=51 Participants • Physician age is reported as a study specific outcome measure so that the total means are not mixed between participants and physicians.
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=26 Participants
|
10 Participants
n=25 Participants
|
8 Participants
n=24 Participants
|
31 Participants
n=75 Participants
|
|
Sex/Gender, Customized
Female
|
13 Participants
n=26 Participants
|
14 Participants
n=25 Participants
|
16 Participants
n=24 Participants
|
43 Participants
n=75 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=26 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=26 Participants
|
19 Participants
n=25 Participants
|
19 Participants
n=24 Participants
|
61 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=26 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=26 Participants
|
1 Participants
n=25 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=26 Participants
|
2 Participants
n=25 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=26 Participants
|
2 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=75 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=26 Participants
|
25 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
75 Participants
n=75 Participants
|
|
Marital Status
Not Married
|
15 Participants
n=26 Participants • Protocol had no plans to collect marital status from physicians.
|
10 Participants
n=25 Participants • Protocol had no plans to collect marital status from physicians.
|
—
|
25 Participants
n=51 Participants • Protocol had no plans to collect marital status from physicians.
|
|
Marital Status
Married
|
11 Participants
n=26 Participants • Protocol had no plans to collect marital status from physicians.
|
15 Participants
n=25 Participants • Protocol had no plans to collect marital status from physicians.
|
—
|
26 Participants
n=51 Participants • Protocol had no plans to collect marital status from physicians.
|
|
Education
<4 yrs College
|
8 Participants
n=26 Participants
|
11 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
19 Participants
n=75 Participants
|
|
Education
Bachelor's Degree
|
7 Participants
n=26 Participants
|
6 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
13 Participants
n=75 Participants
|
|
Education
Graduate
|
11 Participants
n=26 Participants
|
8 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
43 Participants
n=75 Participants
|
|
Employment
Unemployed
|
7 Participants
n=26 Participants
|
8 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
15 Participants
n=75 Participants
|
|
Employment
Employed
|
19 Participants
n=26 Participants
|
17 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
60 Participants
n=75 Participants
|
|
Income
<50k
|
7 Participants
n=26 Participants • Protocol had no plans to collect income status from physicians.
|
8 Participants
n=25 Participants • Protocol had no plans to collect income status from physicians.
|
—
|
15 Participants
n=51 Participants • Protocol had no plans to collect income status from physicians.
|
|
Income
50k-99k
|
10 Participants
n=26 Participants • Protocol had no plans to collect income status from physicians.
|
7 Participants
n=25 Participants • Protocol had no plans to collect income status from physicians.
|
—
|
17 Participants
n=51 Participants • Protocol had no plans to collect income status from physicians.
|
|
Income
100k+
|
9 Participants
n=26 Participants • Protocol had no plans to collect income status from physicians.
|
10 Participants
n=25 Participants • Protocol had no plans to collect income status from physicians.
|
—
|
19 Participants
n=51 Participants • Protocol had no plans to collect income status from physicians.
|
|
Number of Children
No Children
|
14 Participants
n=26 Participants • Protocol had no plans to collect number of children data from physicians.
|
13 Participants
n=25 Participants • Protocol had no plans to collect number of children data from physicians.
|
—
|
27 Participants
n=51 Participants • Protocol had no plans to collect number of children data from physicians.
|
|
Smoking Status
Non-Smoker
|
25 Participants
n=26 Participants • Protocol had no plans to collect smoking status from physicians.
|
23 Participants
n=25 Participants • Protocol had no plans to collect smoking status from physicians.
|
—
|
48 Participants
n=51 Participants • Protocol had no plans to collect smoking status from physicians.
|
|
Smoking Status
Smoker
|
1 Participants
n=26 Participants • Protocol had no plans to collect smoking status from physicians.
|
2 Participants
n=25 Participants • Protocol had no plans to collect smoking status from physicians.
|
—
|
3 Participants
n=51 Participants • Protocol had no plans to collect smoking status from physicians.
|
|
Age of Physicians, Continuous
|
—
|
—
|
41.83 years
STANDARD_DEVIATION 10.47 • n=24 Participants • This measure is for physician age only so it does not include patient participant data, in order to have the patient participant data mean totals remain accurate. Therefore patient participants are not analyzed here.
|
41.83 years
STANDARD_DEVIATION 10.47 • n=24 Participants • This measure is for physician age only so it does not include patient participant data, in order to have the patient participant data mean totals remain accurate. Therefore patient participants are not analyzed here.
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, and 9 monthsPopulation: Per protocol, only control arm patients were to have a 9 month assessment.
Count of participants who have been prescribed antidepressant medications which are not contraindicated
Outcome measures
| Measure |
Delayed Intervention (Control Arm)
n=25 Participants
Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
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.
|
PGx Test
n=25 Participants
Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
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.
|
|---|---|---|
|
Count of Participants Prescribed Antidepressant Medication
Baseline
|
5 Participants
|
8 Participants
|
|
Count of Participants Prescribed Antidepressant Medication
Month 3
|
5 Participants
|
8 Participants
|
|
Count of Participants Prescribed Antidepressant Medication
Month 6
|
6 Participants
|
8 Participants
|
|
Count of Participants Prescribed Antidepressant Medication
Month 9
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: PHQ-8 data is unavailable for 8 participants in the control arm and 7 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up.
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.
Outcome measures
| Measure |
Delayed Intervention (Control Arm)
n=25 Participants
Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
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.
|
PGx Test
n=25 Participants
Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
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.
|
|---|---|---|
|
Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)
Baseline
|
9.0 score on a scale
Standard Deviation 4.4
|
8.6 score on a scale
Standard Deviation 6.1
|
|
Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)
6 month
|
7.5 score on a scale
Standard Deviation 4.3
|
5.8 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Because GAD-7 data is unavailable for 8 participants in the control arm and 7 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up, the data is presented for those participants who had both data points so comparisons between the two time points are appropriate.
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.
Outcome measures
| Measure |
Delayed Intervention (Control Arm)
n=17 Participants
Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
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.
|
PGx Test
n=18 Participants
Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
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.
|
|---|---|---|
|
Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)
baseline
|
9.1 score on a scale
Standard Deviation 6.2
|
6.9 score on a scale
Standard Deviation 5.6
|
|
Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)
Month 6
|
6.1 score on a scale
Standard Deviation 5.0
|
5.2 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: ARMs data is unavailable for 10 participants in the control arm and 8 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up.
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.
Outcome measures
| Measure |
Delayed Intervention (Control Arm)
n=15 Participants
Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
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.
|
PGx Test
n=17 Participants
Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
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.
|
|---|---|---|
|
Change in Adherence to Refills and Medication Scale (ARMS) Scores
baseline
|
17.1 score on a scale
Standard Deviation 3.3
|
17.4 score on a scale
Standard Deviation 3.2
|
|
Change in Adherence to Refills and Medication Scale (ARMS) Scores
6 month
|
17 score on a scale
Standard Deviation 2.5
|
16.6 score on a scale
Standard Deviation 3.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 monthsAcceptability of PGx testing in primary care among persons taking a target antidepressant and primary care physicians who care for them
Outcome measures
Outcome data not reported
Adverse Events
Delayed Intervention (Control Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PGx Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place