Lurasidone in adolescents with schizophrenia: Sustained remission and recovery during 2 years of open-label treatment

Abstract

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 andNegative Symptom Scale (PANSS) total score ≥70 and <120, were randomized to 6 weeks of doubleblind (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.