Status:
COMPLETED
An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay
Lead Sponsor:
Genomind, LLC
Conditions:
Treatment Resistant Depression
Generalized Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Genomind has developed and introduced a battery of genetic tests, the Genecept Assay, which clinicians can administer to patients using a simple saliva sample technique. The present study proposes to ...
Detailed Description
This will be a 3-month prospective study of clinicians who have ordered the Genecept assay and the psychiatric patients for whom the test was ordered. Clinicians who order the Assay for a patient who ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
685 Patients enrolled
Trial Details
Trial ID
NCT01507155
Start Date
April 1 2013
End Date
May 1 2014
Last Update
June 8 2016
Active Locations (1)
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1
Genomind, LLC
Chalfont, Pennsylvania, United States, 18914