John M Kane1, Ronghua Yang, James M Youakim. 1. Department of Psychiatry, The Zucker Hillside Hospital, 75-59 263rd Street, Kaufmann Bldg, Suite 103, Glen Oaks, NY 11004–1150, USA. JKane2@NSHS.edu
Abstract
OBJECTIVE: A prior 4-week, proof-of-concept study suggested that adjunctive therapy with armodafinil 200mg/day decreases negative symptoms in patients with clinically stable schizophrenia. This study investigated the efficacy and tolerability of adjunctive armodafinil for treatment of negative symptoms in adults with schizophrenia receiving antipsychotic medications. METHODS: This parallel-group, 24-week study enrolled adults with schizophrenia who were receivingoral olanzapine, risperidone, or paliperidonefor ≥ 6 weeks, and had a Positive and Negative Syndrome Scale (PANSS) negative symptom subscale score of ≥ 15. Patients received one of 3 doses of once-daily armodafinil (150 mg, 200mg, or 250 mg) or placebo. The primary efficacy measure was the change from baseline to final visit in the PANSS negative symptom subscale score. Secondary measures included the PANSS total score, Clinical Global Impression of Severity, Personal and Social Performance Scale, and CNSVitalSigns cognitive battery. RESULTS: Of 285 randomized patients, 213 received armodafinil and 72 received placebo. The mean (SD) changes in PANSS negative symptom subscale score were -1.9 (3.8) for armodafinil 150 mg (n = 70), -2.3 (3.6) for armodafinil 200mg (n = 69), -2.0 (3.3) for armodafinil 250 mg (n = 71), and -2.2 (4.1) for placebo (n=70) (p ≥ 0.70 for each armodafinil group versus placebo). Secondary measures were generally not different between groups. Armodafinil was generally well tolerated, without worsening positive symptoms. CONCLUSIONS: This study found no benefit of adjunctive armodafinil versus placebo for negative symptoms in patients with schizophrenia receiving treatment witholanzapine, risperidone, or paliperidone. Armodafinil was generally well tolerated in these patients.
RCT Entities:
OBJECTIVE: A prior 4-week, proof-of-concept study suggested that adjunctive therapy with armodafinil 200mg/day decreases negative symptoms in patients with clinically stable schizophrenia. This study investigated the efficacy and tolerability of adjunctive armodafinil for treatment of negative symptoms in adults with schizophrenia receiving antipsychotic medications. METHODS: This parallel-group, 24-week study enrolled adults with schizophrenia who were receiving oral olanzapine, risperidone, or paliperidone for ≥ 6 weeks, and had a Positive and Negative Syndrome Scale (PANSS) negative symptom subscale score of ≥ 15. Patients received one of 3 doses of once-daily armodafinil (150 mg, 200mg, or 250 mg) or placebo. The primary efficacy measure was the change from baseline to final visit in the PANSS negative symptom subscale score. Secondary measures included the PANSS total score, Clinical Global Impression of Severity, Personal and Social Performance Scale, and CNSVitalSigns cognitive battery. RESULTS: Of 285 randomized patients, 213 received armodafinil and 72 received placebo. The mean (SD) changes in PANSS negative symptom subscale score were -1.9 (3.8) for armodafinil 150 mg (n = 70), -2.3 (3.6) for armodafinil 200mg (n = 69), -2.0 (3.3) for armodafinil 250 mg (n = 71), and -2.2 (4.1) for placebo (n=70) (p ≥ 0.70 for each armodafinil group versus placebo). Secondary measures were generally not different between groups. Armodafinil was generally well tolerated, without worsening positive symptoms. CONCLUSIONS: This study found no benefit of adjunctive armodafinil versus placebo for negative symptoms in patients with schizophrenia receiving treatment with olanzapine, risperidone, or paliperidone. Armodafinil was generally well tolerated in these patients.
Authors: Javier Ortiz-Orendain; Sergio A Covarrubias-Castillo; Alan Omar Vazquez-Alvarez; Santiago Castiello-de Obeso; Gustavo E Arias Quiñones; Maya Seegers; Luis Enrique Colunga-Lozano Journal: Cochrane Database Syst Rev Date: 2019-12-12
Authors: Igne Sinkeviciute; Marieke Begemann; Merel Prikken; Bob Oranje; Erik Johnsen; Wan U Lei; Kenneth Hugdahl; Rune A Kroken; Carina Rau; Jolien D Jacobs; Silvia Mattaroccia; Iris E Sommer Journal: NPJ Schizophr Date: 2018-10-25