Clinical Trial: Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Protocol 331-13-009: An Exploratory, Multicenter, Randomized, Double-Blind, fMRI Study of Fixed-dose Brexpiprazole (OPC-34712) (2 and 4 mg/Day Tablets) in Adults With Schizophrenia With

  • Change from baseline brain activation in the VLPFC based on change from baseline to Week 6 in fMRI blood oxygen-level dependent (BOLD) activation score in the right VLPFC during performance of the Go/No-go Task [ Time Frame: Week 6 ]
  • Change from baseline brain activation in the VLPFC based on change from baseline to Week 6 in fMRI BOLD activation score in the right VLPFC during performance of the SSRT Task [ Time Frame: Week 6 ]


    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change from baseline to Week 3 in fMRI BOLD activation score in the right VLPFC, scanned by fMRI during performance of tasks associated with impulsivity (SSRT Task, Go/No-go Task) [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11) [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in BIS-11 [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in Go/No-go Task behavior [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in Go/No-go Task behavior [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in Monetary Choice Questionnaire (MCQ) score [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in MCQ score [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in Stop Signal Reaction Time Task (SSRT) Task behavior [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in SSRT Task behavior [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in Continuous Performance Task (CPT) behavior [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in CPT behavior [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in PANSS Total Score [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in PANSS Positive Subscale Score [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in PANSS Positive Subscale Score [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in PANSS Negative Subscale Score [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in PANSS Negative Subscale Score [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) score [ Time Frame: Week 6 ]
    • Change from baseline to Week 3 in CGI-S score [ Time Frame: Week 3 ]
    • Clinical Global Impression - Improvement Scale (CGI-I) score at Week 6 [ Time Frame: Week 6 ]
    • CGI-I score at Week 3 [ Time Frame: Week 3 ]
    • Change from baseline to Week 6 in Personal and Social Performance Scale (PSP) [ Time Frame: Week 6 ]


    Original Secondary Outcome: Same as current

    Information By: Otsuka Pharmaceutical Development & Commercialization, Inc.

    Dates:
    Date Received: July 16, 2014
    Date Started: February 2015
    Date Completion:
    Last Updated: August 11, 2016
    Last Verified: August 2016