:
1. Subject is aged ≥18 to <65 years at the time of randomization
2. Subject is capable of providing signed Informed Consent Form before any study
assessments will be performed
3. Subject has a primary diagnosis of schizophrenia established by a comprehensive
psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini
International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder
Studies (MINI) version 7.0.2
4. Subject is currently being treated with stable dosing of monotherapy risperidone,
paliperidone, aripiprazole, or their LAIs ziprasidone, lurasidone, or cariprazine
and has been taking this treatment with the same dosing regimen for at least 8 weeks
at the time of Day 1 (Visit 3)
5. The subject has had at least 1 previous inadequate response to above antipsychotics
that was dosed appropriately (within the label) for at least 6 weeks
6. The subject has not required psychiatric hospitalization, incarceration in prison,
acute crisis intervention, or other increase in the level of care due to symptom
exacerbation within 8 weeks of Screening and is psychiatrically stable in the
opinion of the Investigator
7. To be eligible for randomization, subjects need to have detectable levels of
background antipsychotic medication (measured at Visit 1)
8. Positive and Negative Syndrome Scale (PANSS) total score ≥ 70 at Screening and
randomization
9. Clinical Global Impression-Severity (CGI-S) scale with a score ≥ 4 (moderate) at
Screening and randomization
10. PANSS Marder Positive symptom factor ≥ 4 on 2 (or more) items (PANSS items,
delusions, hallucinations, grandiosity, suspiciousness and persecution, stereotyped
thinking, somatic concern, unusual thought content or lack of judgment and insight),
at Screening and randomization
11. Subjects with ≤ 20-point decrease in PANSS Total score between Visit 1 and Visit 3
12. Subject is willing and able to visit the clinic in an outpatient setting for the
study duration, follow instructions, and comply with the protocol requirements
13. Body Mass Index (BMI) must be within 18 to 40 kg/m2 (inclusive of both values)
14. Subject resides in a stable living situation in the opinion of the Investigator
15. Subject has identified a reliable informant/ caregiver willing and able to assist
with study activities as needed throughout the subject's participation in the study.
The informant needs to be physically present at the Baseline visit, but can complete
the remaining study visits assessments via phone (as needed and as per local
regulations). In Bulgaria, the informant needs to physically present at the Baseline
visit and should be physically present at all study visits where the Investigator
determines that his/her input would be beneficial.
16. Women of childbearing potential (WOCP), or men whose sexual partners are WOCP, must
be able and willing to use at least 1 highly effective method of contraception
during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last
dose of study drug. Sperm donation is not allowed for 30 days after the final dose
of the study drug. A female subject is considered to be a WOCP after menarche and
until she is in a postmenopausal state for 12 months or otherwise permanently
sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy,
or bilateral oophorectomy)
Recruiting
