Trial Outcomes & Findings for PRIME Care (PRecision Medicine In MEntal Health Care) (NCT NCT03170362)
NCT ID: NCT03170362
Last Updated: 2024-05-28
Results Overview
The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Remission was defined as a score of 5 or less at the endpoint. the reported number of participants are those reaching that threshold of symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1944 participants
Primary outcome timeframe
24 weeks post randomization
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
Intervention Group
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
|---|---|---|
|
Overall Study
STARTED
|
966
|
978
|
|
Overall Study
COMPLETED
|
754
|
787
|
|
Overall Study
NOT COMPLETED
|
212
|
191
|
Reasons for withdrawal
| Measure |
Intervention Group
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
23
|
22
|
|
Overall Study
Lost to Follow-up
|
187
|
167
|
Baseline Characteristics
PRIME Care (PRecision Medicine In MEntal Health Care)
Baseline characteristics by cohort
| Measure |
Intervention Group
n=966 Participants
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
n=978 Participants
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
Total
n=1944 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 15 • n=99 Participants
|
47 years
STANDARD_DEVIATION 15 • n=107 Participants
|
48 years
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=99 Participants
|
262 Participants
n=107 Participants
|
491 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
737 Participants
n=99 Participants
|
716 Participants
n=107 Participants
|
1453 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
113 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
850 Participants
n=99 Participants
|
869 Participants
n=107 Participants
|
1719 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
185 Participants
n=99 Participants
|
167 Participants
n=107 Participants
|
352 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
644 Participants
n=99 Participants
|
688 Participants
n=107 Participants
|
1332 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
90 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
966 Participants
n=99 Participants
|
978 Participants
n=107 Participants
|
1944 Participants
n=206 Participants
|
|
Depression severity
|
17.5 units on a scale
STANDARD_DEVIATION 4.3 • n=99 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 4.3 • n=107 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 4.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeks post randomizationThe investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Remission was defined as a score of 5 or less at the endpoint. the reported number of participants are those reaching that threshold of symptoms.
Outcome measures
| Measure |
Intervention Group
n=754 Participants
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
n=787 Participants
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
|---|---|---|
|
Depression Remission
|
130 Participants
|
126 Participants
|
PRIMARY outcome
Timeframe: Over the first 30 daysThe investigators will examine the proportion of antidepressants prescribed in the first 30 days of the trial that have the potential for gene-drug interactions. The chance for a gene-drug interaction was classified as 1. the subject did not have a prescription for an antidepressant during the initial 4 weeks of the trial (No Antidepressant), 2 the subject was prescribed an antidepressant with no known gene-drug interaction (No Gene Interaction), 3 the subject was prescribed an antidepressant with moderate gene-drug interactions (Moderate Interaction). These are also gene-drug interactions that do not have level A concordance. And 4. the subject was prescribed an antidepressant with substantial gene-drug interactions or gene-drug interactions that are considered to have a high level of evidence to support other prescribing.
Outcome measures
| Measure |
Intervention Group
n=966 Participants
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
n=978 Participants
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
|---|---|---|
|
Use of Fewer Medications That Have Potential Gene-drug Interactions
No Antidepressant prescibed
|
239 Participants
|
299 Participants
|
|
Use of Fewer Medications That Have Potential Gene-drug Interactions
Taking an antidepressant with no gene interaction
|
433 Participants
|
173 Participants
|
|
Use of Fewer Medications That Have Potential Gene-drug Interactions
Taking an antidepressant with moderate gene interaction
|
215 Participants
|
373 Participants
|
|
Use of Fewer Medications That Have Potential Gene-drug Interactions
Taking an antidepressant with substantial gene interaction
|
79 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: 24 WeeksThe investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self-assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. This measure will use the PHQ9 as a continuous measure. The reported outcome is the difference in scores from baseline to 24 weeks.
Outcome measures
| Measure |
Intervention Group
n=754 Participants
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
n=787 Participants
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
|---|---|---|
|
Depression Severity
|
5.4 units on a scale
Standard Deviation 5.9
|
4.8 units on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 24 weeksThe investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Response was measured by a 50% reduction in scores from baseline to each time point.
Outcome measures
| Measure |
Intervention Group
n=754 Participants
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
n=787 Participants
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
|---|---|---|
|
Depression Response
|
242 Participants
|
216 Participants
|
Adverse Events
Intervention Group
Serious events: 76 serious events
Other events: 650 other events
Deaths: 2 deaths
Delay Results Group
Serious events: 70 serious events
Other events: 636 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Intervention Group
n=966 participants at risk
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
n=978 participants at risk
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
1.1%
11/966 • Number of events 11 • 24 weeks
|
0.82%
8/978 • Number of events 9 • 24 weeks
|
|
Ear and labyrinth disorders
Hospitalization
|
0.21%
2/966 • Number of events 2 • 24 weeks
|
0.20%
2/978 • Number of events 2 • 24 weeks
|
|
Endocrine disorders
Hospitalization
|
0.31%
3/966 • Number of events 6 • 24 weeks
|
0.20%
2/978 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Hospitalization
|
0.83%
8/966 • Number of events 10 • 24 weeks
|
1.2%
12/978 • Number of events 13 • 24 weeks
|
|
Blood and lymphatic system disorders
Hospitalization
|
0.10%
1/966 • Number of events 1 • 24 weeks
|
0.10%
1/978 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Hospitalization
|
0.83%
8/966 • Number of events 8 • 24 weeks
|
0.61%
6/978 • Number of events 8 • 24 weeks
|
|
Nervous system disorders
Hospitalization
|
0.62%
6/966 • Number of events 6 • 24 weeks
|
0.72%
7/978 • Number of events 7 • 24 weeks
|
|
Psychiatric disorders
Hospitalization
|
1.9%
18/966 • Number of events 24 • 24 weeks
|
1.8%
18/978 • Number of events 24 • 24 weeks
|
|
Social circumstances
Incarceration
|
0.00%
0/966 • 24 weeks
|
0.10%
1/978 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.41%
4/966 • Number of events 5 • 24 weeks
|
0.41%
4/978 • Number of events 7 • 24 weeks
|
|
Renal and urinary disorders
Hospitalization
|
0.10%
1/966 • Number of events 1 • 24 weeks
|
0.20%
2/978 • Number of events 2 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
1.3%
13/966 • Number of events 13 • 24 weeks
|
0.72%
7/978 • Number of events 8 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization
|
0.10%
1/966 • Number of events 1 • 24 weeks
|
0.00%
0/978 • 24 weeks
|
Other adverse events
| Measure |
Intervention Group
n=966 participants at risk
Pharmacogenetic test results will be provided to the provider within 72 hours of randomization in order to facilitate choice in selecting antidepressants.
Pharmacogenetic Test: The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
|
Delay Results Group
n=978 participants at risk
The comparator arm will not receive results at the time of randomization but will get results after the 24 week assessment (thus the results are delayed).
|
|---|---|---|
|
Nervous system disorders
Headache
|
35.7%
345/966 • Number of events 676 • 24 weeks
|
37.8%
370/978 • Number of events 705 • 24 weeks
|
|
Reproductive system and breast disorders
Sexual side effects
|
42.3%
409/966 • Number of events 982 • 24 weeks
|
41.1%
402/978 • Number of events 1026 • 24 weeks
|
|
Gastrointestinal disorders
GI distress
|
28.2%
272/966 • Number of events 461 • 24 weeks
|
24.0%
235/978 • Number of events 417 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
28.2%
272/966 • Number of events 461 • 24 weeks
|
24.0%
235/978 • Number of events 417 • 24 weeks
|
|
Nervous system disorders
Fatigue
|
13.5%
130/966 • Number of events 185 • 24 weeks
|
11.0%
108/978 • Number of events 161 • 24 weeks
|
|
Nervous system disorders
Insomnia
|
5.6%
54/966 • Number of events 64 • 24 weeks
|
6.3%
62/978 • Number of events 75 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place