Summary:
A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia.
This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.
Inclusion criteria:
The main inclusion criteria include, but are not limited to the following:
- Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
- Subject meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the subject's diagnosis must be ≥ 1 year prior to Screening.
- Subject must have a CGI-S score ≤ 4 at Screening and Baseline.
- Subject must have a PANSS total score ≤ 80 at Screening and Baseline.
- Subject is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening.
- Subject has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening.
- Subjects taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator).
- Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis).
Qualified Participants May Receive:
Monetary compensation and study-related care at no cost to the participant.