An Open Label Study of the Genecept™ Assay in Treatment Resistant Depression

Withdrawn before enrolling · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01438242

Run by

Genomind, LLC

People needed

0

Starts

2015-01-01

Expected to finish

2016-01-01

Last updated by the study team

2015-03-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Exclusion Criteria:
• Inability to complete online surveys
• Patient selected in conjunction with the clinician chooses not to participate

Where it is running

• Genomind, LLC — Chalfont, Pennsylvania, United States

Full record on ClinicalTrials.gov

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