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

This study is not yet open for participant recruitment.
Verified February 2014 by Genomind, LLC
Sponsor:
Information provided by (Responsible Party):
Genomind, LLC
ClinicalTrials.gov Identifier:
NCT01438242
First received: September 20, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Device: Genecept Assay

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Open Label Study of the Genecept™ Assay to Evaluate Efficacy of Using Assay Guided Treatment in Outpatient Adults With Treatment Resistant Depression

Resource links provided by NLM:


Further study details as provided by Genomind, LLC:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in Quick Inventory of Depressive Symptoms (QIDS-SR1), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung self-rated anxiety scales at 3 months.

  • Medication Adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To compare medication adherence between Patient subjects and matched control cohort

  • Resource Utilization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To determine the comparative effectiveness of AGT versus Treatment as Usual (TAU) in a matched control cohort in outpatient management of nonpsychotic Major Depressive Disorder patients with treatment resistant depression, as measured by total claims.

  • Impact of Specific Genetic Variants [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    1. To explore genetic variants within the patient population and identify subgroups for whom pharmacogenetic testing is particularly informative
    2. To determine which specific results of pharmacogenetic testing have the most impact on clinician behavior

  • Side Effects [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To explore genetic variants in relationship to classes of medications and treatment response as measured by CGI and QIDs, and change in reported adverse events using the UKU (The Udvalg for Kliniske Undersøgelser Side Effect Rating Scale.)


Estimated Enrollment: 200
Study Start Date: January 2015
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assay Guided Treatment - Genecept Asay
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
Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
Other Name: Genetic Test
Experimental: Clinician's utilizing Assay Guided Treatment in Psychiatry
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
Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
Other Name: Genetic Test

Detailed Description:

Genomind is sponsoring an open label study of Assay Guided Treatment (AGT) using the Genecept Assay in adult outpatients with Treatment Resistant Major Depressive Disorder. The Genecept Assay is a Clinical Laboratory Improvement Amendments (CLIA) laboratory validated test being researched to determine if having information about genetic variations impacts patient outcomes.

The proposed investigation will examine the potential impact of the Assay in terms of depression severity as measured by change in CGI scale at 3 months. Secondary measures will assess change in Quick Inventory of Depressive Symptoms (QIDS-SR), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung self-rated anxiety scales at 3 months. Additional measures include change in clinician treatment and diagnosis decisions and impact on mediation side effects using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU). Participant data will be compared to a matched control cohort to assess the impact of the use of the Genecept Assay on medication adherence and total claims.

Patients with a diagnosis of non-psychotic Major Depressive Disorder will be identified. These patients and their treating clinicians will be recruited. The present study proposes to enroll 1. Subjects (patients who are identified as eligible) and 2. Clinician study participants (clinicians who are identified as responsible for the care of eligible 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.

Potential subjects and study participants will consent electronically on a secure study portal. Patients and Clinicians must both consent to participate in order to proceed in the study. After both subjects and clinician study participants have consent to participate, they will each be asked to complete an electronic baseline survey. Once the baseline survey is completed, the clinician will receive the Genecept Assay by mail and will then supervise collection of a saliva DNA sample during a routine office visit.

At baseline, month 1 and month 3, patient Subjects will be prompted to complete surveys which include questions about their psychiatric symptoms, quality of life and medication side effects. The 3 month patient assessment will also include a satisfaction questionnaire.

At baseline, clinician study participants will be prompted to complete a brief survey containing questions about the patient's psychiatric history and severity of illness, current treatment regimen and the treatment intentions of the clinician prior to receiving genetic results. After receiving the results of the Assay, clinician study participants will again be prompted to complete an online study survey containing questions related to the impact of the Genecept Assay on treatment and diagnosis decisions. The subject will continue with treatment as determined by the clinician study participant. At 3 months from baseline, clinician study participants will again be asked to complete an online survey with additional questions related to subsequent changes to the patient's treatment regimen and illness severity since receiving/implementing the results of the Assay.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Subjects:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438242

Contacts
Contact: Rachel Dicker, PharmD 215-396-5594 rachel.dicker@genomind.com

Locations
United States, Pennsylvania
Genomind, LLC Not yet recruiting
Chalfont, Pennsylvania, United States, 18914
Contact: Rachel Dicker, PharmD    215-396-5594    rachel.dicker@genomind.com   
Contact: Frank Brennan, PhD    215-396-5588    frank.brennan@genomind.com   
Sponsors and Collaborators
Genomind, LLC
Investigators
Principal Investigator: Herbert Harris, MD, PhD Rho
  More Information

No publications provided

Responsible Party: Genomind, LLC
ClinicalTrials.gov Identifier: NCT01438242     History of Changes
Other Study ID Numbers: AT1
Study First Received: September 20, 2011
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Genomind, LLC:
Major
Depressive
Disorder
Depression
Treatment Resistant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014