An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay (COM-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genomind, LLC
ClinicalTrials.gov Identifier:
NCT01507155
First received: January 6, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Treatment Resistant Depression
Generalized Anxiety 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 Clinical Utility and Patient Outcomes of the Genecept Assay

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-SR16), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung Self-Rated Anxiety (SAS) scales at 3 months.


Enrollment: 685
Study Start Date: April 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assay Guided Treatment
Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay.
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:

This will be a 3-month prospective study of clinicians who have ordered the Genecept assay and the psychiatric patients for whom the test was ordered. Clinicians who order the Assay for a patient who has been indicated as having a diagnosis of depression will receive an invitation to participate in this study as well as an informational patient study brochure with the test kit. The patient's treating clinician will be prompted to discuss the study with the patient. Clinicians and patients can view a website containing additional information about the study as well as the informed consent document.

Potential subjects and clinician study participants will be consented online using a secure electronic method. Study staff will be available by phone and by email to answer any questions related to the study and the informed consent documents and process. Clinicians and patients can choose to participate independently of each other so that if one party declines to enroll, the other may still participate. Whether or not they choose to participate, patients must consent to allow their clinicians to provide responses about their treatment.

All subjects and participants will receive a username and password with which to access the secure study portal for completion of study surveys. Subjects and participants will receive sms and email reminders when surveys are due.

At baseline, clinician study participants will supervise DNA sample collection and 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.

The subject will also be prompted to complete surveys at baseline, 1 month from the receipt of the genetic results and 3 months from the receipt of the genetic results. These surveys include questions about the patient's psychiatric symptoms, quality of life and medication side effects. The 3 month patient assessment will also include a satisfaction questionnaire.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinician Study Participants:

  • Valid 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507155

Locations
United States, Pennsylvania
Genomind, LLC
Chalfont, Pennsylvania, United States, 18914
Sponsors and Collaborators
Genomind, LLC
Investigators
Principal Investigator: Herb Harris, MD, PhD Genomind, LLC
  More Information

No publications provided

Responsible Party: Genomind, LLC
ClinicalTrials.gov Identifier: NCT01507155     History of Changes
Other Study ID Numbers: COM-1
Study First Received: January 6, 2012
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014