An observational study in Pharmacogenetic Testing, sponsored by Seattle Institute for Biomedical and Clinical Research. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Seattle Institute for Biomedical and Clinical Research · Observational
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Among 140 studies in Drug-Related Side Effects and Adverse Reactions with a site in United States — 13 open to participants now, 18 under way, 2 of them phase 3. Drug-Related Side Effects and Adverse Reactions · United States.
Among the 140 studies in Drug-Related Side Effects and Adverse Reactions with a site in United States, this one is the 28th largest by enrollment of the 35 observational ones that give a count, is one of 6 that started in 2018, is one of 35 observational ones, and was the 91st registered.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
Browse Drug-Related Side Effects and Adverse Reactions studies →13 of the 140 studies in Drug-Related Side Effects and Adverse Reactions with a site in United States are open now. Recruiting first, the newest first:
Texas A&M University · Sites in United States
Ages 18–100
Florida Atlantic University · Sites in United States
Ages 65–110
Eli Lilly and Company · Sites in United States, Australia, China and 7 more countries
Ages 18+
Texas A&M University · Sites in United States
Ages 18+
Brigham and Women's Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 55 Drug-Related Side Effects and Adverse Reactions studies recruiting now, 37 (67%) set no upper age limit and 15 (27%) stop at 75 or younger; 14 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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140 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 27 · Phase 3 14 · Phase 4 11
First in 1993; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 53 is below the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Median enrollment 96 across the 95 interventional studies, 200 across the 35 observational. Of the 102 that completed or were terminated, 26 (25%) have results posted.
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22 of 140 have an industry lead sponsor. The 10 most frequent:
Seattle Institute for Biomedical and Clinical Research is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Seattle Institute for Biomedical and Clinical Research has 1 study filed under Drug-Related Side Effects and Adverse Reactions — fewer than ten, so there is no comparison to draw.
6 of the studies in Drug-Related Side Effects and Adverse Reactions with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05358535Phase 3University of Texas Southwestern Medical CenterPropofol and Etomidate Admixtures Comparisons Trial (PEAC Trial) | 2027-01 |
| NCT05084196Phase 3Rutgers, The State University of New JerseyMelatonin for Prevention of Kidney Injury | 2027-06-01 |
| NCT06219720Texas A&M UniversityThe Texas Interprofessional Pharmacogenomics (IPGx) | 2026-11 |
| NCT07169851Eli Lilly and CompanyA Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer | 2026-12 |
| NCT05838638University of Central FloridaSerious Gaming for Chemotherapy-induced Nausea and Vomiting | 2027-06-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 140 studies in Drug-Related Side Effects and Adverse Reactions with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects. Pharmacogenetic assays, such as the Genecept® Assay, have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. Thus, this study is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing and a computerized decision tool for providers to determine the potential efficacy of the assay to reduce polypharmacy and improve patient outcomes.
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and increased the risk of drug-drug interactions and adverse side effects. Pharmacogenetic assays have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. One such assay is the Genecept® Assay produced by Genomind, which detects 63 allele polymorphisms of 18 genes. In addition, Genomind has developed the Genomind Drug Interaction Guide (G-DIG), which examines drug-drug-gene interactions. This computerized decision tool for medication providers uses the genetic information from the Genecept® Assay to look at the current medications being utilized to determine if there are specific drug-drug interactions that may be relevant given the individual's specific genetic test results.
This is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing information to both providers and patients. Fifty Veterans within the VAPSHCS who are prescribed polypharmacy, as defined as five or more medications, with at least two prescribed for a mental health diagnosis, and have a sub-optimal treatment effect will be enrolled in this study. Participating subjects will sign informed consent and a sample will be obtained in order to complete the pharmacogenomic testing. Medication providers who are participating in this study will utilize the pharmacogenetic assay results along with the G-DIG tool to design an optimized medication regime. The overall global level of symptoms and other patient symptoms measures will be administered at baseline, 6-weeks, and 12-weeks. The provider's medication plans will be compared before and after the pharmacogenetic assay information is provided. Number of medications will be reviewed to determine any reduction in polypharmacy and healthcare costs. The clinical global improvement scale (CGI) and patient assessments, including measures of depression, anxiety, PTSD, insomnia, pain, drug and alcohol use, quality of life, side effects, and medication adherence will be administered at baseline, 6-weeks, and 12-weeks.
The subject pool will be drawn from Veterans receiving care at VA Puget Sound Health Care System for mental health diagnosis between the ages of 18-75 who meet all of the inclusion criteria with no indicators to any of the exclusionary criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Veterans who have been 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 medication for side effects related to a medication prescribed for the mental health diagnosis.
Genetic: Genecept Assay and G-DIG decision tool
Participating providers will review results of the Genecept Assay using a secure web-based program and will utilize the G-DIG tool in order 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
Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.
Time frame: Baseline and 12-weeks
Number of Psychiatric Medications
Number of psychiatric medications prescribed to the patient.
Time frame: Change from baseline to 12-weeks
Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 is a scale of depression, scores range from 0-27, with 0 representing less depression and 27 representing more depression.
Time frame: Change from baseline to 12-weeks
Generalized Anxiety Scale-7 (GAD-7)
Generalized Anxiety Scale-7 is a measure of anxiety, scores range from 0-21, with 0 representing less anxiety and 7 representing more anxiety.
Time frame: Change from baseline to 12-weeks
recruitment lasted from 10/04/2017 to 12/31/2018
| Milestone | Genecept Assay and G-DIG Decision Tool |
|---|---|
| Started | 53 |
| Completed | 47 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 2 |
Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.
| units on a scale | Genecept Assay and G-DIG Decision Tool |
|---|---|
| CGI at baseline | 4.07 ± .62 |
| CGI at 12-weeks | 3.96 ± .59 |
Number of psychiatric medications prescribed to the patient.
| prescriptions | Genecept Assay and G-DIG Decision Tool |
|---|---|
| Psychiatric meds at baseline | 3.85 ± 1.41 |
| Psychiatric meds at 12-weeks | 3.70 ± 1.37 |
Patient Health Questionnaire-9 is a scale of depression, scores range from 0-27, with 0 representing less depression and 27 representing more depression.
| scores | Genecept Assay and G-DIG Decision Tool |
|---|---|
| PHQ-9 at baseline | 15.81 ± 5.68 |
| PHQ-9 at 12-weeks | 13.43 ± 6.39 |
Generalized Anxiety Scale-7 is a measure of anxiety, scores range from 0-21, with 0 representing less anxiety and 7 representing more anxiety.
| units on a scale | Genecept Assay and G-DIG Decision Tool |
|---|---|
| GAD-7 at baseline | 13.60 ± 5.53 |
| GAD-7 at 12-weeks | 12.02 ± 5.90 |
Collected over Baseline, 6-weeks, 12-weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Genecept Assay and G-DIG Decision Tool | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
Participants as described in data tables.
| Age, Categorical(Participants) | Genecept Assay and G-DIG Decision Tool |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 41 |
| >=65 years | 12 |
| Sex: Female, Male(Participants) | Genecept Assay and G-DIG Decision Tool |
|---|---|
| Female | 18 |
| Male | 35 |
| Ethnicity (NIH/OMB)(Participants) | Genecept Assay and G-DIG Decision Tool |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 48 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Genecept Assay and G-DIG Decision Tool |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 5 |
| White | 36 |
| More than one race | 7 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Genecept Assay and G-DIG Decision Tool |
|---|---|
| United States | 53 |
| CGI(units on a scale) | Genecept Assay and G-DIG Decision Tool |
|---|---|
| Mean | 4.07 ± .62 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Apr 2019, 15 months.
Results were first posted in Feb 2022, 2 years 10 months after primary completion.
Of 65 non-industry observational studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24. This study's 15 months is below that.
Counting every sponsor, half of 69 studies reached it within 45 months; a quarter within 24 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Seattle Institute for Biomedical and Clinical Research