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

Primary Purpose

Treatment Resistant Depression, Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genecept Assay
Sponsored by
Genomind, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Treatment Resistant Depression focused on measuring Major, Depressive, Disorder, Depression, MDD, Treatment Resistant, Anxiety, GAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Genomind, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient-Reported Measures

Clinician-Reported Outcomes

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months
To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in self-reported patients scales: Quick Inventory of Depressive Symptoms (QIDS-SR16) scale; scores range from 0-27, 0 means no depression and 27 means very severe depression Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) scale; scores range from 0-100 and greater scores correspond with greater satisfaction with quality of life Undersøgelser (UKU) scale that measures degree of side effects from total scores ranging from 0-100; 0-40 refers to low side effects and 81-100 referring to high side effects rating the Zung Self-Rated Anxiety (SAS) scale measures anxiety severity using the total scores ranging from 20-80; 20-44 being normal and 75-80 meaning most severe

Full Information

First Posted
January 6, 2012
Last Updated
May 5, 2016
Sponsor
Genomind, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01507155
Brief Title
An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay
Acronym
COM-1
Official Title
An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genomind, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Generalized Anxiety Disorder
Keywords
Major, Depressive, Disorder, Depression, MDD, Treatment Resistant, Anxiety, GAD

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
685 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-Reported Measures
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinician-Reported Outcomes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Genecept Assay
Other Intervention Name(s)
Genetic Test
Intervention Description
Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
Primary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months
Description
To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in self-reported patients scales: Quick Inventory of Depressive Symptoms (QIDS-SR16) scale; scores range from 0-27, 0 means no depression and 27 means very severe depression Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) scale; scores range from 0-100 and greater scores correspond with greater satisfaction with quality of life Undersøgelser (UKU) scale that measures degree of side effects from total scores ranging from 0-100; 0-40 refers to low side effects and 81-100 referring to high side effects rating the Zung Self-Rated Anxiety (SAS) scale measures anxiety severity using the total scores ranging from 20-80; 20-44 being normal and 75-80 meaning most severe
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herb Harris, MD, PhD
Organizational Affiliation
Genomind, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genomind, LLC
City
Chalfont
State/Province
Pennsylvania
ZIP/Postal Code
18914
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26445691
Citation
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.
Results Reference
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An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay

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