Status:
WITHDRAWN
An Open Label Study of the Genecept™ Assay in Treatment Resistant Depression
Lead Sponsor:
Genomind, LLC
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the potential impact of the assay in terms of depression severity as measured by change in Clinical Global Impressions (CGI) scale at 3 months.
Detailed Description
Genomind is sponsoring an open label study of Assay Guided Treatment (AGT) using the Genecept Assay in adult outpatients with Treatment Resistant Major Depressive Disorder. The Genecept Assay is a Cli...
Eligibility Criteria
Inclusion
- Subjects:
- Age 18-65 years
- Ability to complete electronic informed consent
- Includes:
- access to appropriate technology (i.e. internet-connected device, internet connection),
- cognitively competent
- Eligible participants will have one or more of the following diagnoses for 12 months or longer: 296.2x, 296.3x
- Must have had self-insured Aetna Behavioral Health, Medical, and Pharmacy benefits for that 12-month period.
- QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit
- Must have had an initial prescription plus two refills of two antidepressants from different GPI4 levels.
- Must have access to the secure web-portal to complete self-assessments
Exclusion
- Clinician selected in conjunction with the patient chooses not to participate
- Psychotic features in the current episode, based upon clinical assessment
- Inpatient behavioral health hospitalization within six months prior to the study
- Four or more failed pharmacologic interventions in the current major depressive episode \[response rates for these Subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects\]
- Current substance use disorder assessed as being of a severity that requires inpatient or outpatient detoxification
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception
- Women who are breastfeeding
- Serious suicide or homicide risk, as assessed by evaluating clinician
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests
- Patients who have taken an investigational psychotropic drug within the last three months
- Clinician Study Participants:
- Inclusion Criteria :
- Treating clinician for potential Patient subjects identified for the study
- Valid NPI number
- Signed electronic informed consent
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01438242
Start Date
January 1 2015
End Date
January 1 2016
Last Update
March 23 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Genomind, LLC
Chalfont, Pennsylvania, United States, 18914