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

NCT01438242 | Withdrawn

• 1 other identifier: AT1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major; Depressive; Disorder; Depression; Treatment Resistant

Outcome Measures

Primary Outcomes (1)

• Efficacy

  To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in Clinical Global Impressions (CGI) scale at 3 months.

  3 Months

Secondary Outcomes (5)

• Efficacy

  3 months

• Medication Adherence

  3 months

• Resource Utilization

  3 months

• Impact of Specific Genetic Variants

  3 months

• Side Effects

  3 months

Study Arms (2)

Assay Guided Treatment - Genecept Asay

EXPERIMENTAL

Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account. Genetic analysis is performed using the Genecept Assay, a genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders

Device: Genecept Assay

Clinician's utilizing Assay Guided Treatment in Psychiatry

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

Assay Guided Treatment - Genecept Asay; Clinician's utilizing Assay Guided Treatment in Psychiatry

Eligibility Criteria

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

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:
• Treating clinician for potential Patient subjects identified for the study
• Valid NPI number
• Signed electronic informed consent
• Inability to complete online surveys

Sponsors & Collaborators

• Genomind, LLC: lead

Study Sites (1)

Genomind, LLC

Chalfont, Pennsylvania, 18914, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Disease; Depression

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

Study Officials

• Herbert Harris, MD, PhD

  Rho, Inc.

  PRINCIPAL INVESTIGATOR

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: September 20, 2011
• First Posted: September 22, 2011
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

US (1)