N/A Completed N=685 Supportive Care

An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay

Depression · Anxiety

Source: ClinicalTrials.gov NCT01507155 ↗

Enrolled (actual)

685

Serious AEs

0.0%

Results posted

May 2016

Primary outcomePrimary: Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months — 545; 386 Participants

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 enroll 1. Subjects (patients who have consented to using the Genecept Assay) and 2. Clinician study participants (clinicians who have ordered the Assay on behalf of their patients). This study will involve the collection of responses from both Subjects and clinician study participants with the intention of correlating this information to Subject genetic data.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months	545; 386	—
SECONDARY Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months	7.8; 50.0; 19.2; 35.9	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01507155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.