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Clinical Decision Support

Pharmacogenetic-Guided Treatment for Depression (ADOPT PGx Trial)

N/A
Waitlist Available
Led By Hrishikesh Chakraborty
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

ADOPT PGx Trial Summary

This trial tests if genetic testing and genotype-guided anti-depressant therapy can reduce depression symptoms.

Who is the study for?
This trial is for English or Spanish speakers aged 8 years and above with depression, who are starting or changing SSRI therapy at participating clinics. They must have had depressive symptoms for at least 3 months. Excluded are those too ill to consent, planning to move soon, with bipolar disorder, seizure disorders, certain genetic test results, psychosis, dementia or cognitive disabilities.Check my eligibility
What is being tested?
The Depression Trial compares immediate pharmacogenetic testing and tailored anti-depressant therapy against standard care with delayed testing. It aims to see if personalized treatment based on how a person's body processes SSRIs can better reduce depression symptoms.See study design
What are the potential side effects?
While the trial description does not specify side effects of interventions directly since it involves standard care practices and genetic testing which typically do not involve medication side effects; however general SSRI side effects may include nausea, sleep issues, agitation or anxiety.

ADOPT PGx Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3 Month Depression Symptom Control Change from Baseline
Secondary outcome measures
3 Month Change in PHQ of Depression Symptomatology Change from Baseline Scores
3 Month Medication Adherence Change from Baseline
3 Month Medication Side Effect Burden Change from Baseline
+1 more

ADOPT PGx Trial Design

2Treatment groups
Experimental Treatment
Group I: Depression - Immediate PGx TestingExperimental Treatment2 Interventions
Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
Group II: Depression - Delayed PGx TestingExperimental Treatment1 Intervention
Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,418,608 Total Patients Enrolled
74 Trials studying Depression
32,895 Patients Enrolled for Depression
National Human Genome Research Institute (NHGRI)NIH
263 Previous Clinical Trials
282,671 Total Patients Enrolled
Hrishikesh ChakrabortyPrincipal InvestigatorDuke University
4 Previous Clinical Trials
13,515 Total Patients Enrolled
1 Trials studying Depression
4,111 Patients Enrolled for Depression

Media Library

Clinical decision support (Clinical Decision Support) Clinical Trial Eligibility Overview. Trial Name: NCT05966155 — N/A
Depression Research Study Groups: Depression - Immediate PGx Testing, Depression - Delayed PGx Testing
Depression Clinical Trial 2023: Clinical decision support Highlights & Side Effects. Trial Name: NCT05966155 — N/A
Clinical decision support (Clinical Decision Support) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05966155 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research currently have open enrollment?

"Per clinicaltrials.gov, this medical investigation is actively accepting participants. It was initially published on July 1st 2021 and underwent an edit on the 21st of July 2023."

Answered by AI

To what extent have medical centers adopted this research endeavor?

"This research is recruiting patients from University of Florida - Gainesville in Gainesville, Florida, University of Florida - Jacksonville in Jacksonville, Indiana and Eskenazi Health in Orlando, New york with an additional 14 sites."

Answered by AI

How many participants are enrolled in this research project?

"1512 qualified applicants are necessary to begin the trial. Individuals have access to the study through different sites, including University of Florida - Gainesville and University of Florida - Jacksonville."

Answered by AI

Who else is applying?

What site did they apply to?
Indiana University
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

What are the steps with the trial?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I’ve had depression many years of my life. Over this time period I’ve tried many antidepressants with no success.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)
2021. "A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05966155.
All > Depression Raleigh > Fargo
~0 spots leftby Apr 2024
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