N/A
N=685
An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay
Treatment Resistant Depression · Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01507155 ↗Enrolled (actual)
685
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months — 545; 386 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Genecept Assay (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genomind, LLC
- Primary completion
- May 2014
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 | — |
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.
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
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.