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Pharmacogenetic Test for Mental Health Disorders (PRIME Care 2 Trial)
PRIME Care 2 Trial Summary
This trial is designed to see if PGx testing can help reduce polypharmacy (use of multiple medications) among Veterans with mental illness.
PRIME Care 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRIME Care 2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PRIME Care 2 Trial Design
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Who is running the clinical trial?
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- I am taking a long-term antidepressant and another psychotropic medication regularly.- You are between 18 and 80 years old.
- You have a score of more than 9 on the PHQ-9 questionnaire.
- You are currently taking at least one antidepressant from the Sanford PGx panel and at least one other medication for mental health conditions such as antidepressants, antipsychotics, "mood stabilizers," addiction medications, or benzodiazepines. Medications taken for less than 2 months will not count.
- You agree to give a blood sample for genetic testing.
- You meet the requirements for the PHASER test according to current guidance.
- You agree to give informed consent to participate in the study.I am willing to give a blood sample for genetic testing.I do not have a current psychotic illness like schizophrenia.I am in the hospital now but can come back for the study after I'm discharged.I am between 18 and 80 years old.
- Group 1: Immediate return of results
- Group 2: Delayed return of results
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this trial accept participants aged 85 or older?
"This study is open to those within the 18-80 age range."
How many participants are currently enrolled in this research study?
"Affirmative. The information posted on clinicaltrials.gov testifies that this medical trial is presently in search of participants. It was first advertised on June 2nd, 2020 and the last update came through July 6th 2021 with a demand for 500 patients to be recruited from one site."
Are there any openings for participants in this medical research?
"Confirming the details on clinicaltrials.gov, this medicinal experiment is still recruiting patients. It was initially released to the public on June 2nd 2020 and has been modified as recenty as July 6th 2021."
To whom is the opportunity to participate in this experiment available?
"To apply for this medical research, potential participants must have a psychiatric or mood-related disorder and be aged between 18 to 80. To date, approximately 500 individuals have been accepted into the study."
Has the FDA authorized Pharmacogenetic testing?
"The safety of pharmacogenetic testing has been well established, so it was awarded a score of 3."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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