MYnd Analytics Directed Therapy in Depression

Mynd Analytics has developed the Psychiatric Electroencephalography Evaluation Registry
(PEER) Online® clinical decision support database that uses a combination of software,
analytics, and clinical outcomes to provide objective, adjunctive medication response
information to physicians treating patients with non-psychotic behavioral disorders. PEER
Online uses a statistical analysis of EEG outputs and other patient information to generate a
report that indicates the statistical likelihood of the patient's responsiveness to classes
of central nervous system (CNS) medications (i.e. antidepressants), groups (i.e. SSRI) and
individual agents (i.e. fluoxetine). A discriminant analysis compares neurophysiologic
abnormalities of the patient to patterns of abnormalities of known responders to CNS drugs in
the company's outcomes database of symptomatic patients. This provides a probability estimate
of the similarity of the patient's profile with the profile of groups of individuals
constituting the normative and clinical (symptomatic) database, which provides the treating
physician guidance to which treatments the patient will most likely respond to, and those
treatments to which the patient is least likely to respond.

Procedurally, PEER Online utilizes standard 21-lead digital electroencephalographic equipment
measuring the patient in a resting (but awake) state. The recording generally takes 30-60
minutes. Patients are classified based upon the 1,142 variables calculated in the recording
(FDA-approved neurometric system) and categorized based on the outcome history in treating
patients with similar neurophysiologic outputs. From these outputs and the correlation to the
outcome database, reports may indicate single or multiple medications based on the nature of
the physiologic abnormality discovered. The entire procedure is rapid, non-invasive, devoid
of radiation or high strength magnetic fields, and results in a report, the PEER Outcome
Report that is provided to clinicians in a format similar to antibiotic sensitivity testing.

Study Design (summary)

1. The patient population will consist of individuals with depression who in the opinion of
their physician require medication management. A score of 10 or more on the PHQ-9
instrument will be required for enrollment. Non-psychotic co-morbid illnesses will be
permitted. Patients must not currently be receiving psychotropic medications (including
stimulants, benzodiazepines, or THC). Patients previously on these medications but off
treatment for >30 days are permitted.

2. The physician will declare whether they wish to treat the depression or refer to a
participating psychiatrist. Individual physicians (prior to enrolling any patients) will
be assigned to either agree to utilize MYnd Analytic directed care or to be part of the
control cohort. This will minimize any physician learning effect.

3. The patient will sign informed consent to participate.

4. All patients will undergo a study related EEG and MYnd Analytics will develop a PEER
Online report. The report will be released to the treating physicians in the directed
care group but will not be released to the control physicians.

5. All patients will complete a disease specific assessment tool (QIDS-SR16) at every
office visit (at a minimum assessments at baseline, 3 months into treatment, and 6
months into treatment). Patients choosing to withdraw from the study or from treatment
will also be offered the assessment at participation endpoint. COTA will score each
patient based on the standardized tools as either improved, stable, or worsened. The
primary endpoint for this study is QIDS-SR16 percent mean change from baseline, with
response being defined as a reduction of >50% from baseline. Physicians may know the
results of these tests and may alter therapy per their usual practice.

6. Medication management will be at the final discretion of the treating physician.
Physicians assigned to the MYnd Analytics directed care cohort will be encouraged, but
not required, to follow the PEER Online report. Any change in therapy will be documented
by the physician with reason (lack of efficacy, toxicity, patient preference).

Inclusion Criteria:

- Patients with a clinical diagnosis of depression who in the judgement of their
physician require medication management may be eligible for enrollment. A score of 10
or more on the PHQ-9 instrument will be required for enrollment.

- Some practices utilize the PHQ-2 and PHQ-9 are part of routine screening for
depression. If the tests are performed routinely, they do not need to be repeated for
study eligibility, and may be performed prior to informed consent for this study. If,
however, the PHQ-9 is not routinely performed, informed consent must be performed
prior to administration. Patients with a score below 10 will be considered screen
failures and will not be enrolled or offered the MYnd testing.

- Patients with non-psychotic comorbid conditions may be included.

- Patients must be either medication treatment naïve for behavioral illnesses or have no
active medication treatments for at least 1 month prior to enrollment. Prohibited
medications at the time of enrollment will include stimulants, benzodiazepines and
THC. Prior therapy with these agents is permitted with a washout of >30 days.

- Patients must have private medical insurance coverage through Horizon Blue Cross Blue
Shield. This is limited to insured commercial members, including HMO, and excluding,
for the avoidance of doubt, members of self-insured customers or Medicare or Medicaid
programs.

Exclusion Criteria:

- Diagnosis of a psychotic disorder.

- History of, or current, open head brain trauma. Candidates with any metal, shrapnel or
other similar objects in the head that could affect the QEEG

- History of: craniotomy, cerebral metastases, cerebrovascular accident; current
diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia,
mental retardation, or major depression with psychotic features; or use of depot
neuroleptics in last 12 months.

- Uncontrolled thyroid disorders.

- Known pregnancy and/or lactation, or intent to become pregnant during this study.

- Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic
narcotic)

- Participation in any other therapeutic drug study within 60 days preceding inclusion.