title: Adjunctive armodafinil for negative symptoms in adults with schizophrenia: a double-blind, placebo-controlled study.
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 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.affiliation: Department of Psychiatry, The Zucker Hillside Hospital, 75-59 263rd Street, Kaufmann Bldg, Suite 103, Glen Oaks, NY 11004–1150, USA. JKane2@NSHS.edu
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
authors.forename: Ronghua
authors.initials: R
authors.lastname: Yang
authors.forename: James M
authors.initials: JM
authors.lastname: Youakim
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000008:administration & dosage; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology*; D012565:Schizophrenic Psychology; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil