Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility.

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.

Inclusion Criteria:

• Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2
• Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria.
• Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule.
• Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms.

Exclusion Criteria:

• Participants with current major depressive disorder (MDD)
• Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
• Participants currently using anticholinergic medications
• Participants recently hospitalized as in-patients

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/