Testing the Value of Smartphone Assessments of People With Mood Disorders

Progress in psychiatry will require better measurement. Currently, few clinicians use
standard rating instruments for either diagnosis or outcomes. As a result, clinicians often
fail to detect when a patient is not improving and fail to adjust treatments accordingly. Yet
even with the use of standard rating instruments, there are serious shortcomings because they
are used episodically, usually in an office environment, and they rely solely on subjective
reports. Given the importance of objective measures of mood, anxiety, and cognition, it is
critical for clinicians and patients to have better assessments if we are to achieve better
mental healthcare.

The advent of smartphones provides a potential solution for the lack of objective
measurement. The wide use of phones gives us the opportunity to collect passive, objective,
continuous data relevant to mood, anxiety, and cognition. While several studies have
demonstrated the feasibility of digital phenotyping psychiatric patients, the clinical value
of this approach has yet to be demonstrated.

Stated simply the question is: can the data from a smartphone be used in clinical practice to
improve care? Specifically, will sensor data, keyboard behavior, or voice and speech metrics
yield features that can be validated with clinical assessments? Can these features identify
relapse and remission even before clinical change is apparent with traditional ratings? Will
this information alter care and improve outcomes? This pilot investigation is designed to
answer the questions about validation and prediction by studying mood changes in patients
treated with ketamine, a rapid-acting antidepressant. The final question about care and
outcomes will be addressed separately.

Thus, the current study is a 6 month open, exploratory study that follows longitudinally
patients with MDD or BD who are receiving outpatient treatment at the Kadima Clinic. The
Kadima Clinic is a private outpatient mental health service providing a range of treatments
for people with mood disorders. All patients will be receiving ketamine treatment in the
Kadima Clinic; however, this is a study of smartphone features as digital biomarkers, not a
study of ketamine efficacy or safety. While the ketamine treatment will not be the focus of
this study, its rapid efficacy yields an ideal opportunity for testing and tuning the
Mindstrong digital phenotyping app. There will not be randomization, use of placebo, or
administration of blinded medication. Patients will be selected based on their willingness to
participate in clinical assessments and their use of a smartphone.

The design includes screening and assessment during the week prior to treatment and follow-up
at regular intervals for at least 3 weeks and no more than 6 months following treatment.
Assessments will be completed by the patient, by a trained clinical rater, and by a
significant other.

After completing the enrollment consent, the Mindstrong application (app) is installed in
each participant's smartphone. The app is resident on the participant's mobile phone for 6
months. The participant can at any time choose to uninstall the app. The Mindstrong app
unobtrusively monitors the participant's use of the mobile phone. The data captured by the
app is transmitted over secure channel to a secure data storage site on Amazon Web Services
(AWS) cloud infrastructure. All data captured by the app is encrypted.

Inclusion Criteria:

- Adult male or female aged 18 to 65 years (inclusive) at time of informed consent

- Diagnosis of Major Depression Disorder (MDD) or Bipolar Disorder (BD) as assessed
using the Structured Clinical Interview for DSM Disorders-Clinical Trials (SCID-CT)

- Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 26; Patient Health Questionnaire
(PHQ-9) ≥ 15; Clinical Global Impression (CGI) ≥ 4 at screening

- Ownership of a personal smartphone and willingness to install and maintain the
Mindstrong app for digital assessments throughout participation in the study

- Able to understand and comply with instructions in English

- Has a significant other who accompanies participant to treatment appointments and
agrees to complete assessments

- Undergoing ketamine treatment at the Kadima Clinic, or determined by the Kadima Clinic
to be eligible for ketamine treatment and agrees to receive such treatment prior to
being asked to participate in this research

Exclusion Criteria:

- Female who is currently pregnant or planning a pregnancy within 6 months

- Has any other current Axis I DSM-5 disorder other than MDD or BD, which is the primary
focus of treatment

- Has any other clinically significant medical condition or circumstance that, in the
opinion of the Investigator, could affect patient safety, preclude evaluation of
response, interfere with the ability to comply with study procedures, or prohibit
completion of the study

- Has a visual or physical motor impairment that could interfere with study tasks

- Is site personnel directly affiliated with this study