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

Joshua T. Kantrowitz, Zafar Sharif, Alice Medalia, Richard S E Keefe, Philip D Harvey, Gerard Bruder, Deanna M. Barch, Tse Choo, Seonjoo Lee, Jeffrey A. Lieberman

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Objective: 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. Method: 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. Results: 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 betweentreatment group differences at study completion. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)799-806
Number of pages8
JournalJournal of Clinical Psychiatry
Volume77
Issue number6
DOIs
StatePublished - Jun 1 2016

Fingerprint

Psychotic Disorders
Schizophrenia
Video Games
Random Allocation
Consensus
Nootropic Agents
Cognitive Remediation
Lurasidone Hydrochloride
Research Ethics Committees
Diagnostic and Statistical Manual of Mental Disorders
Antipsychotic Agents
Outcome Assessment (Health Care)
Brain

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

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. / Kantrowitz, Joshua T.; Sharif, Zafar; Medalia, Alice; Keefe, Richard S E; Harvey, Philip D; Bruder, Gerard; Barch, Deanna M.; Choo, Tse; Lee, Seonjoo; Lieberman, Jeffrey A.

In: Journal of Clinical Psychiatry, Vol. 77, No. 6, 01.06.2016, p. 799-806.

Research output: Contribution to journalArticle

Kantrowitz, Joshua T. ; Sharif, Zafar ; Medalia, Alice ; Keefe, Richard S E ; Harvey, Philip D ; Bruder, Gerard ; Barch, Deanna M. ; Choo, Tse ; Lee, Seonjoo ; Lieberman, Jeffrey A. / 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. In: Journal of Clinical Psychiatry. 2016 ; Vol. 77, No. 6. pp. 799-806.
@article{fa0c8def18e1485986b82768297490c0,
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 = "Objective: 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. Method: 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. Results: 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 betweentreatment group differences at study completion. Conclusions: 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.",
author = "Kantrowitz, {Joshua T.} and Zafar Sharif and Alice Medalia and Keefe, {Richard S E} and Harvey, {Philip D} and Gerard Bruder and Barch, {Deanna M.} and Tse Choo and Seonjoo Lee and Lieberman, {Jeffrey A.}",
year = "2016",
month = "6",
day = "1",
doi = "10.4088/JCP.15m09998",
language = "English (US)",
volume = "77",
pages = "799--806",
journal = "Journal of Clinical Psychiatry",
issn = "0160-6689",
publisher = "Physicians Postgraduate Press Inc.",
number = "6",

}

TY - JOUR

T1 - 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

AU - Kantrowitz, Joshua T.

AU - Sharif, Zafar

AU - Medalia, Alice

AU - Keefe, Richard S E

AU - Harvey, Philip D

AU - Bruder, Gerard

AU - Barch, Deanna M.

AU - Choo, Tse

AU - Lee, Seonjoo

AU - Lieberman, Jeffrey A.

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Objective: 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. Method: 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. Results: 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 betweentreatment group differences at study completion. Conclusions: 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.

AB - Objective: 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. Method: 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. Results: 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 betweentreatment group differences at study completion. Conclusions: 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.

UR - http://www.scopus.com/inward/record.url?scp=84976384886&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84976384886&partnerID=8YFLogxK

U2 - 10.4088/JCP.15m09998

DO - 10.4088/JCP.15m09998

M3 - Article

C2 - 27035157

AN - SCOPUS:84976384886

VL - 77

SP - 799

EP - 806

JO - Journal of Clinical Psychiatry

JF - Journal of Clinical Psychiatry

SN - 0160-6689

IS - 6

ER -