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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: Completed NA study, sponsored by Mclean Hospital.
NCT03113890 is a NA study that has completed, run by Mclean Hospital. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This aim will test if, by the 3-month follow-up, inpatient psychopharmacogenetic testing will reduce symptoms of depression and anxiety.
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 |
What the finished NCT03113890 record still lists
NCT03113890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Phlebotomy - Folate is the first listed.
NCT03113890 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03113890's enrollment target sits among peer trials
75 1069th of 2000 higher than 919 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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