An Open Label Study of the Genecept™ Assay in Treatment Resistant Depression

Genomind is sponsoring an open label study of Assay Guided Treatment (AGT) using the
Genecept Assay in adult outpatients with Treatment Resistant Major Depressive Disorder.
The Genecept Assay is a Clinical Laboratory Improvement Amendments (CLIA) laboratory
validated test being researched to determine if having information about genetic variations
impacts patient outcomes.

The proposed investigation will examine the potential impact of the Assay in terms of
depression severity as measured by change in CGI scale at 3 months. Secondary measures will
assess change in Quick Inventory of Depressive Symptoms (QIDS-SR), Quality of Life
Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Zung self-rated anxiety scales at 3
months. Additional measures include change in clinician treatment and diagnosis decisions
and impact on mediation side effects using the Udvalg for Kliniske Undersøgelser Side Effect
Rating Scale (UKU). Participant data will be compared to a matched control cohort to assess
the impact of the use of the Genecept Assay on medication adherence and total claims.

Patients with a diagnosis of non-psychotic Major Depressive Disorder will be identified.
These patients and their treating clinicians will be recruited. The present study proposes
to enroll 1. Subjects (patients who are identified as eligible) and 2. Clinician study
participants (clinicians who are identified as responsible for the care of eligible
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.

Potential subjects and study participants will consent electronically on a secure study
portal. Patients and Clinicians must both consent to participate in order to proceed in the
study. After both subjects and clinician study participants have consent to participate,
they will each be asked to complete an electronic baseline survey. Once the baseline survey
is completed, the clinician will receive the Genecept Assay by mail and will then supervise
collection of a saliva DNA sample during a routine office visit.

At baseline, month 1 and month 3, patient Subjects will be prompted to complete surveys
which include questions about their psychiatric symptoms, quality of life and medication
side effects. The 3 month patient assessment will also include a satisfaction questionnaire.

At baseline, clinician study participants 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.

Subjects:

Inclusion Criteria:

- Age 18-65 years

- Ability to complete electronic informed consent

Includes:

- access to appropriate technology (i.e. internet-connected device, internet
connection),

- cognitively competent

- Eligible participants will have one or more of the following diagnoses for 12
months or longer: 296.2x, 296.3x

- Must have had self-insured Aetna Behavioral Health, Medical, and Pharmacy
benefits for that 12-month period.

- QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit

- Must have had an initial prescription plus two refills of two antidepressants
from different GPI4 levels.

- Must have access to the secure web-portal to complete self-assessments

Exclusion Criteria:

- Clinician selected in conjunction with the patient chooses not to participate

- Psychotic features in the current episode, based upon clinical assessment

- Inpatient behavioral health hospitalization within six months prior to the study

- Four or more failed pharmacologic interventions in the current major depressive
episode [response rates for these Subjects is likely to be extremely low and would
require a substantially larger-scale study to identify treatment effects]

- Current substance use disorder assessed as being of a severity that requires
inpatient or outpatient detoxification

- Pregnant women or women of child bearing potential who are not using a medically
accepted means of contraception

- Women who are breastfeeding

- Serious suicide or homicide risk, as assessed by evaluating clinician

- Unstable medical illness including cardiovascular, hepatic, renal, respiratory,
endocrine, neurological, or hematological disease, based on review of medical
history, physical examination, and screening laboratory tests

- Patients who have taken an investigational psychotropic drug within the last three
months

Clinician Study Participants:

Inclusion Criteria :

- Treating clinician for potential Patient subjects identified for the study

- Valid NPI number

- Signed electronic informed consent

Exclusion Criteria:

- Inability to complete online surveys

- Patient selected in conjunction with the clinician chooses not to participate