title: A Multicenter, Rater-Blinded, Randomized Controlled Study of Auditory Processing-Focused Cognitive Remediation Combined With Open-Label Lurasidone in Patients With Schizophrenia and Schizoaffective Disorder.
abstract: Small-scale studies of auditory processing cognitive remediation programs have demonstrated efficacy in schizophrenia. We describe a multicenter, rater-blinded, randomized, controlled study of auditory-focused cognitive remediation, conducted from June 24, 2010, to June 14, 2013, and approved by the local institutional review board at all sites.
  
  
  
  Prior to randomization, participants with schizophrenia (DSM-IV-TR) were stabilized on a standardized antipsychotic regimen (lurasidone [40-160 mg/d]), followed by randomization to adjunctive cognitive remediation: auditory focused (Brain Fitness) versus control (nonspecific video games), administered 1-2 times weekly for 30 sessions. Coprimary outcome measures included MATRICS Consensus Cognitive Battery (MCCB) and the University of California, San Diego, Performance-Based Skills Assessment-Brief scale.
  
  
  
  120 participants were randomized and completed at least 1 auditory-focused cognitive remediation (n = 56) or video game control session (n = 64). 74 participants completed ≥ 25 sessions and postrandomization assessments. At study completion, the change from prestabilization was statistically significant for MCCB composite score (d = 0.42, P < .0001) across groups. Participants randomized to auditory-focused cognitive remediation had a trend-level higher mean MCCB composite score compared to participants randomized to control cognitive remediation (P = .08). After controlling for scores at the time of randomization, there were no significant between-treatment group differences at study completion.
  
  
  
  Auditory processing cognitive remediation combined with lurasidone did not lead to differential improvement over nonspecific video games. Across-group improvement from prestabilization baseline to study completion was observed, but since all participants were receiving lurasidone open label, it is difficult to interpret the source of these effects. Future studies comparing both pharmacologic and behavioral cognitive enhancers should consider a 2 × 2 design, using a control for both the medication and the cognitive remediation.
  
  
  
  ClinicalTrials.gov identifier: NCT01173874.
authors.affiliation: Columbia University Psychiatry, 1051 Riverside Dr, New York, NY 10023. jk3380@cumc.columbia.edu.|Department of Psychiatry, Columbia University, New York, New York, USA.
authors.forename: Joshua T
authors.initials: JT
authors.lastname: Kantrowitz
authors.affiliation: Department of Psychiatry, Columbia University, New York, New York, USA.
authors.forename: Zafar
authors.initials: Z
authors.lastname: Sharif
authors.affiliation: Department of Psychiatry, Columbia University, New York, New York, USA.
authors.forename: Alice
authors.initials: A
authors.lastname: Medalia
authors.affiliation: Department of Psychiatry, Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Richard S E
authors.initials: RS
authors.lastname: Keefe
authors.affiliation: University of Miami Miller School of Medicine, Miami, Florida, USA.
authors.forename: Philip
authors.initials: P
authors.lastname: Harvey
authors.affiliation: Department of Psychiatry, Columbia University, New York, New York, USA.
authors.forename: Gerard
authors.initials: G
authors.lastname: Bruder
authors.affiliation: Department of Psychology, Washington University, St Louis, Missouri, USA.
authors.forename: Deanna M
authors.initials: DM
authors.lastname: Barch
authors.affiliation: Department of Psychiatry, Columbia University, New York, New York, USA.
authors.forename: Tse
authors.initials: T
authors.lastname: Choo
authors.affiliation: Department of Psychiatry, Columbia University, New York, New York, USA.
authors.forename: Seonjoo
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Psychiatry, Columbia University, New York, New York, USA.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Lieberman
mesh_terms: D000293:Adolescent; D000328:Adult; D001308:Auditory Perceptual Disorders / Q000628:therapy*; D000072466:Cognitive Remediation; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000069056:Lurasidone Hydrochloride / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011618:Psychotic Disorders / Q000523:psychology / Q000628:therapy*; D012559:Schizophrenia / Q000628:therapy*; D012565:Schizophrenic Psychology; D016037:Single-Blind Method; D055815:Young Adult
chemical_list: D000069056:Lurasidone Hydrochloride