McLean and Genomind Prospective Study
Completed · Not applicable
Conditions studied: Major Depressive Disorder, PTSD
In brief
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.
Key facts
- Study ID
- NCT03113890
- Run by
- Mclean Hospital
- People needed
- 75
- Starts
- 2017-09-22
- Expected to finish
- 2020-07-31
- Last updated by the study team
- 2021-02-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inpatients admitted to the Short Term Unit at Mclean Ability to understand and sign informed consent. These patients cover a transdiagnostic range of severe depression, anxiety, and PTSD.
- Both genders, all ethnic backgrounds, age 18 or older
- Fluent English speakers
You may not qualify if…
- Involuntary hospitalization
Where it is running
- McLean Hospital — Belmont, Massachusetts, United States
Full record on ClinicalTrials.gov
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