- Otherwise healthy male and/or female subjects between the ages of 18 and 50 years,
inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition
(DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the
M.I.N.I 7.0 for Psychotic Disorders
- Evidence of stable schizophrenia symptomatology >=3 months (ie, no hospitalizations
for schizophrenia, no increase in level of psychiatric care due to worsening of
symptoms of schizophrenia).
- Subjects must be in ongoing maintenance atypical antipsychotic therapy (except
clozapine), on a stable treatment regimen for >=2 months prior to Baseline/Day 1,
including concomitant psychotropic treatments. Subjects should be on no more than 2
- Subject must have an identified informant
- Subject must reside in a stable living situation for at least 12 weeks prior to
- Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of
- Subjects with a current DSM-5 diagnosis of major depressive episode, manic and
hypomanic episode, panic disorder, agoraphobia, social anxiety disorder,
obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety
disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the
- Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia
nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic
Disorders or in the judgment of the investigator.
- Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use
disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I
7.0 for Psychotic Disorders interview and as determined by the investigator.
- Subjects with significant extrapyramidal symptoms which have not been stabilized with