A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Inclusion Criteria:

• Currently meet the Diagnostic and Statistical Manual of Mental Disorders, FifthEdition (DSM-5) criteria for bipolar I disorder, and at least one of the following twocriteria:
• Current episode manic, with or without mixed features, having a total Young ManiaRating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
• OR current episode depressive, with or without mixed features, having aMontgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of atleast 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension orinability to feel).

Exclusion Criteria:

• Four or more episodes of a mood disturbance within the 12 months before Visit 1;
• Diagnosis of another psychiatric disorder other than bipolar disorder with theexception of specific phobias.