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

NCT01507155 | Completed Results

• 1 other identifier: COM-1
• Study Type: interventional
• Target: 685
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Treatment Resistant Depression; Generalized Anxiety Disorder

Keywords

Major; Depressive; Disorder; Depression; MDD; Treatment Resistant; Anxiety; GAD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months

  To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity, as measured by change from baseline using the clinician-administered CGI-I scale, which ranges from scores 1-7 (1=very much improved, 7=very much worse since initiation of treatment).

  3 months

Secondary Outcomes (1)

• Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months

  3 months

Study Arms (2)

Patient-Reported Measures

EXPERIMENTAL

Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who received genetic testing using the Genecept Assay and completed patient scales.

Device: Genecept Assay

Clinician-Reported Outcomes

EXPERIMENTAL

Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.

Device: Genecept Assay

Interventions

Genecept Assay DEVICE

Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders

Also known as: Genetic Test

Clinician-Reported Outcomes; Patient-Reported Measures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genomind, LLC: lead

Study Sites (1)

Genomind, LLC

Chalfont, Pennsylvania, 18914, United States

Location

Related Publications (1)

• Brennan FX, Gardner KR, Lombard J, Perlis RH, Fava M, Harris HW, Scott R. A Naturalistic Study of the Effectiveness of Pharmacogenetic Testing to Guide Treatment in Psychiatric Patients With Mood and Anxiety Disorders. Prim Care Companion CNS Disord. 2015 Apr 16;17(2):10.4088/PCC.14m01717. doi: 10.4088/PCC.14m01717. eCollection 2015.

  PMID: 26445691 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Generalized Anxiety Disorder; Disease; Depression; Anxiety Disorders

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Rachel Scott
• Organization: Genomind

rscott@genomind.com

267-989-3435

Study Officials

• Herb Harris, MD, PhD

  Genomind, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 8, 2016
• Results First Posted: May 2, 2016

Record last verified: 2016-05

Locations

US (1)