Trial Outcomes & Findings for Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population (NCT NCT03468309)

NCT ID: NCT03468309

Last Updated: 2024-04-23

Results Overview

Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.

• Recruitment status: COMPLETED
• Target enrollment: 53 participants
• Primary outcome timeframe: Baseline and 12-weeks
• Results posted on: 2024-04-23

Participant Flow

recruitment lasted from 10/04/2017 to 12/31/2018

Participant milestones

Measure	Genecept Assay and G-DIG Decision Tool Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.
Overall Study STARTED	53
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Genecept Assay and G-DIG Decision Tool Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population

Baseline characteristics by cohort

Measure	Genecept Assay and G-DIG Decision Tool n=53 Participants Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding or removing medications will be determined by the provider.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=93 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	35 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	36 Participants n=93 Participants
Race (NIH/OMB) More than one race	7 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	53 Participants n=93 Participants
CGI	4.07 units on a scale STANDARD_DEVIATION .62 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 12-weeks

Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.

Outcome measures

Measure	Genecept Assay and G-DIG Decision Tool n=50 Participants Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.
Clinical Global Impression CGI at baseline	4.07 units on a scale Standard Deviation .62
Clinical Global Impression CGI at 12-weeks	3.96 units on a scale Standard Deviation .59

SECONDARY outcome

Timeframe: Change from baseline to 12-weeks

Number of psychiatric medications prescribed to the patient.

Outcome measures

Measure	Genecept Assay and G-DIG Decision Tool n=50 Participants Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.
Number of Psychiatric Medications Psychiatric meds at baseline	3.85 prescriptions Standard Deviation 1.41
Number of Psychiatric Medications Psychiatric meds at 12-weeks	3.70 prescriptions Standard Deviation 1.37

SECONDARY outcome

Timeframe: Change from baseline to 12-weeks

Patient Health Questionnaire-9 is a scale of depression, scores range from 0-27, with 0 representing less depression and 27 representing more depression.

Outcome measures

Measure	Genecept Assay and G-DIG Decision Tool n=50 Participants Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.
Patient Health Questionnaire-9 (PHQ-9) PHQ-9 at baseline	15.81 scores Standard Deviation 5.68
Patient Health Questionnaire-9 (PHQ-9) PHQ-9 at 12-weeks	13.43 scores Standard Deviation 6.39

SECONDARY outcome

Timeframe: Change from baseline to 12-weeks

Generalized Anxiety Scale-7 is a measure of anxiety, scores range from 0-21, with 0 representing less anxiety and 7 representing more anxiety.

Outcome measures

Measure	Genecept Assay and G-DIG Decision Tool n=50 Participants Veterans prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.
Generalized Anxiety Scale-7 (GAD-7) GAD-7 at baseline	13.60 units on a scale Standard Deviation 5.53
Generalized Anxiety Scale-7 (GAD-7) GAD-7 at 12-weeks	12.02 units on a scale Standard Deviation 5.90

Adverse Events

Genecept Assay and G-DIG Decision Tool

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

Dr. Amanda E. Wood; Clinical Research Psychologist, VA PSHCS

VA Puget Sound Health Care System

Phone: 253-583-1652

Email: amanda.wood@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place