An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | April 2013 |
| End Date: | June 2014 |
| Contact: | Rachel Dicker |
| Email: | Rachel.Dicker@Genomind.com |
| Phone: | 215-396-5594 |
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.
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.
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.
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.
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
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