| Eligibility |
Inclusion Criteria:
- A participant will be eligible for entry into the study if all of the following
criteria are met:
1. Willing and able to provide written informed consent to participate in the study,
attend study visits, and comply with study-related requirements and assessments.
2. Is an adult at least 18 years of age at the time of informed consent.
3. Fluent in written and spoken English, confirmed by ability to read and understand
the informed consent form.
4. Lives in the United States.
5. Meets diagnostic criteria for a primary diagnosis of schizophrenia as defined in
the International Classification of Diseases, Eleventh Edition (ICD-11) or
Diagnostic Statistical Manual, Fifth Edition (DSM-5) for at least 6 months prior
to screening.
6. Has outpatient treatment status at the time of screening, with no psychiatric
inpatient hospitalization within 13 weeks (3 months) prior to screening.
7. Is currently prescribed at least one typical and/or atypical antipsychotic
medication, and has been on the same antipsychotic medication(s) for at least 13
weeks (3 months) prior to randomization (Day 1). Dose adjustments are permitted
during the study as outlined in the respective package insert(s).
8. Has an average score of >2 in at least 2 domains of Understanding and
communicating, Getting Along with People, Life Activities - Household, or
Participation in Society on the World Health Organization Disability Assessment
Schedule 2.0 (WHO-DAS 2.0).
9. Participant is the only user of an iPhone with iPhone operating system (iOS)
version 14 or later or a smartphone with an Android operating system (OS) version
11 or later and agrees to download and use the digital mobile application as
required by the protocol.
10. Is willing and able to receive SMS text messages and push messages on their
smartphone.
11. Is the owner of and has regular access to an email address.
12. Has regular access to the internet via cellular data plan and/or wi-fi.
13. Has stable housing and has remained at the same residence for at least 13 weeks
(3 months) prior to screening, and does not anticipate housing changes for the
duration of the study.
14. Understands the use of the Study App during the screening period and at the
Baseline Visit, per investigator judgment.
Exclusion Criteria:
- A participant will not be eligible for study entry if any of the following criteria
are met:
1. Has acute prominent positive symptoms that, in the opinion of the investigator,
would preclude effective engagement with the app
2. Is currently receiving or has received concomitant therapy, defined as individual
or group-based structured treatment (e.g., Cognitive Behavioral Therapy, Social
Skills Training, Motivational Interviewing, or Vocational/Occupational Therapy),
within 6 months (26 weeks) prior to screening per investigator assessment.
3. Is currently treated with more than two antipsychotic medications (including more
than 2 dosage forms).
4. Is currently treated with clozapine, or was treated with clozapine within 5 years
of the Screening Visit.
5. Meets ICD-11 or DSM-5 criteria for diagnoses not under investigation that will
impact compliance to the protocol, including schizophreniform, schizoaffective,
or psychosis non-specific disorders (post-traumatic stress disorder [PTSD],
bipolar disorder, major depressive disorder, developmental disorders).
6. Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or
hypomania.
7. Meets ICD-11 or DSM-5 criteria for a current substance or alcohol use disorder
(excluding caffeine and nicotine) within 26 weeks (6 months) of the Screening
Visit. Diagnoses classified as in sustained remission are permitted.
8. In the investigator's opinion, currently needs or will likely require prohibited
concomitant medications and/or therapy during the study.
9. Is at risk for suicide, as defined by any of the following:
1. A "yes" response to either item 4 or 5 on the C-SSRS Suicidal Ideation Items
within the last 13 weeks (3 months) prior to screening or at the Baseline
Visit.
2. A "yes" response on the C-SSRS Suicidal Behavior Items within the last 26
weeks (6 months) prior to screening or at the Baseline Visit.
3. In the opinion of the investigator, presents a serious risk of suicide.
10. Has participated in another clinical study (interventional or observational) in
the last 26 weeks (6 months).
11. Has previously participated in study CT-155-C-001, CT-155-C-002, CT-155-C-003,
CT-155-P-00x, or CT-155-A-001.
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