Lurasidone In Adolescents With Schizophrenia: Sustained Remission And Recovery During 2 Years Of Open-Label Treatment

Introduction Compared with adult onset, early onset schizophrenia is typically characterized by greater illness severity and less favorable prognosis. Objectives To evaluate the proportion of adolescent patients with schizophrenia who achieved sustained remission and recovery during 2 years of treatment with lurasidone. Methods Patients aged 13-17 years with a DSM-IV-TR diagnosis of schizophrenia, and a Positive and Negative Symptom Scale (PANSS) total score ≥70 and <120, were randomized to 6 weeks of double-blind (DB), fixed-dose treatment with lurasidone (37 or 74 mg/d) or placebo. Patients who completed 6 weeks of DB treatment were eligible to enroll in a 2-year, open-label (OL), flexible dose extension study of lurasidone (18.5-74 mg/d). Criteria for sustained remission, were the 6-month consensus criteria summarized by Andreasen (Am J Psych 2005;162:441-9). Criteria for sustained recovery consisted of meeting sustained remission criteria with a Children’s Global Assessment Scale (CGAS) score ≥70 for at least 6-months indicating no clinically significant functional impairment. Results A total of 271 patients completed the 6-week DB study and entered the extension study, and 186 (68.6%) and 156 (57.6%) completed 52 weeks and 104 weeks of treatment, respectively. During OL treatment with lurasidone, 52.8% met sustained remission criteria, with a Kaplan-Meier (KM) estimate of 64.1 weeks for median time to sustained remission; and 28.8% met sustained recovery criteria, KM estimate of 104.6 weeks for median time to sustained recovery. Conclusions For adolescents with schizophrenia, treatment with lurasidone was associated with high rates of sustained remission and sustained recovery over a two-year period. Disclosure Employee of Sunovion Pharmaceuticals Inc. The study summarized in this Abstract was supported by funding from Sunovion Pharmaceuticals Inc