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

Generalized Anxiety Disorder Clinical Trial

— COM-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507155
• Other study ID #: COM-1
• Status: Completed
• Phase: N/A
• First received: January 6, 2012
• Last updated: June 24, 2014
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Genomind, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 685
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder, Treatment-Resistant
• Generalized Anxiety Disorder
• Treatment Resistant Depression

Intervention

Device:
• Genecept Assay
Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders

Locations

Country	Name	City	State
United States	Genomind, LLC	Chalfont	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Genomind, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Efficacy	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.	3 months	No