Clinical trial NCT01507155: An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay
Official title: An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression
Generalized Anxiety Disorder
Keywords: Major
Depressive
Disorder
Depression
MDD
Treatment Resistant
Anxiety
GAD
Lead sponsor: Genomind, LLC
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months
timeFrame: 3 months
Other outcomes:
Locations:
city: Chalfont
country: United States
facility: Genomind, LLC
state: Pennsylvania
Study officials:
affiliation: Genomind, LLC
name: Herb Harris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.