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NCT03113890 · ClinicalTrials.gov registry record · NA
McLean and Genomind Prospective Study
A NA study, sponsored by Mclean Hospital.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT03113890 is a NA study that has completed, run by Mclean Hospital. The registered enrollment target is 75 participants.
The verdict
NCT03113890, a NA study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a three month naturalistic prospective, randomized, open label study of pharmacogenetic testing and clinical outcomes in inpatients across diagnoses, including Treatment Resistant Depression (TRD) with or without Post-Traumatic Stress Disorder (PTSD), recruiting from the Short Term Unit at McLean Hospital. Specifically, the investigators will enroll 200 inpatient subjects over 2 years who will donate saliva/undergo a cheek swab to collect DNA for the Genecept assay. For 100 patients in the assay-guided group, treating Clinicians will receive the Genecept report prior to patient discharge and use it to guide psychoeducation and medication management. For the additional 100 inpatients, treating clinicians will not receive the report during the patient's inpatient stay (treatment as usual. Clinicians will receive the assay report for patients in the treatment-as-usual group at the 3-month followup period. Thus this group will serve as the control group for the outcomes related to Genecept-guided decision making.
Interventions
- GENETIC Phlebotomy - Folate
- GENETIC Cheek Swab
- OTHER Self-report surveys
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-09-22 |
| Est. Completion | 2020-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03113890
The ClinicalTrials.gov registry entry for NCT03113890 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Phlebotomy - Folate is the first listed.
NCT03113890 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03113890 about?
NCT03113890 is a clinical study titled "McLean and Genomind Prospective Study". This is a three month naturalistic prospective, randomized, open label study of pharmacogenetic testing and clinical outcomes in inpatients across diagnoses, including Treatment Resistant Depression (TRD) with or without Post-Traumatic Stress Disorder (PTSD), recruiting from the Short Term Unit at M...
What is the current status of trial NCT03113890?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2017-09-22. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT03113890?
The interventions under investigation include: Phlebotomy - Folate (GENETIC), Cheek Swab (GENETIC), Self-report surveys (OTHER).
Who is sponsoring clinical trial NCT03113890?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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