An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay (COM-1)
Treatment Resistant Depression, Generalized Anxiety Disorder
About this trial
This is an interventional supportive care trial for Treatment Resistant Depression focused on measuring Major, Depressive, Disorder, Depression, MDD, Treatment Resistant, Anxiety, GAD
Eligibility Criteria
Inclusion Criteria:
Clinician Study Participants:
- Valid National Provider Identifier (NPI) number and prescribing privileges
- Signed electronic informed consent
- Signed requisitions form for order of Genecept Assay
- Requisition form includes indication of diagnosis of depression or anxiety for patient
Subject Study Participants:
Ability to complete electronic informed consent; includes:
- access to appropriate technology (i.e. internet-connected device, internet connection),
- cognitively competent
- > or = 18 years old at time of DNA sample collection
- Indication of diagnosis of depression or anxiety on requisition form
Exclusion Criteria:
Clinician Study Participants:
- Inability to complete online questionnaires
Subject Study Participants:
Inability to complete online questionnaires;includes:
- lack of access to appropriate technology (i.e. internet-connected device, internet connection),
- cognitive impairment
- < 18 years old at time of DNA sample collection
Sites / Locations
- Genomind, LLC
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Patient-Reported Measures
Clinician-Reported Outcomes
Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who received genetic testing using the Genecept Assay and completed patient scales.
Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.