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Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

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ClinicalTrials.gov Identifier: NCT02054702
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : December 1, 2015
Last Update Posted : December 30, 2015
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE February 2, 2014
First Posted Date  ICMJE February 4, 2014
Results First Submitted Date  ICMJE August 5, 2015
Results First Posted Date  ICMJE December 1, 2015
Last Update Posted Date December 30, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline to Week 6 ]
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2014)
The change from baseline to Week 6 in PANSS Total Score [ Time Frame: Week 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
  • Change From Baseline in Cognitive Test Battery Composite Score [ Time Frame: Baseline to Week 6 ]
    The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
  • Change From Baseline in Cognitive Test Battery of Early Phase Battery Score [ Time Frame: Baseline to Week 6 ]
    The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task.
  • Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML) [ Time Frame: Baseline to Week 6 ]
    The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
  • Change From Baseline in Cognitive Test Battery Scores of Detection Task [ Time Frame: Baseline to Week 6 ]
    The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
  • Change From Baseline in Cognitive Test Battery Scores of Identification Task [ Time Frame: Baseline to Week 6 ]
    The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
  • Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task [ Time Frame: Baseline to Week 6 ]
    The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.
  • Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Baseline to Week 6 ]
    The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
  • Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6 [ Time Frame: Baseline to Week 6 ]
    The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
  • Response Rate by Study Week [ Time Frame: Baseline to Week 6 ]
    The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved).
  • Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score [ Time Frame: Baseline to Week 6 ]
    The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject's quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 "not well at all" to 5 "very well". The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant.
  • Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score [ Time Frame: Baseline to Week 6 ]
    The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2014)
  • Cognitive test battery composite score change from baseline to Week 6 change from baseline to Week 6 in cognitive test battery composite score change from baseline to Week 6 in cognitive test battery CGI-S score change from baseline to Week 6 [ Time Frame: Week 6 ]
  • CGI-I score at Week 6 [ Time Frame: Week 6 ]
  • Response rate [ Time Frame: Week 6 ]
  • SLOF Total Score change from baseline to Week 6 [ Time Frame: Week 6 ]
  • BIS-11 total score change from baseline to Week 6 [ Time Frame: Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
Official Title  ICMJE Protocol 331-13-008: An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia
Brief Summary The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Brexpiprazole
    Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally
  • Drug: Aripiprazole
    Up to 20 mg/day, once daily dose, tablets, orally
Study Arms  ICMJE
  • Experimental: Brexpiprazole
    Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally
    Intervention: Drug: Brexpiprazole
  • Experimental: Aripiprazole
    Aripiprazole - Up to 20 mg/day, once daily dose, tablets, orally
    Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2014)
97
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2014)
81
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies
  • Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
  • Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
  • Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80
  • Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
  • Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)

Exclusion Criteria:

  • Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
  • Have been hospitalized > 21 days for the current acute episode at the time of the baseline visit
  • Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
  • Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02054702
Other Study ID Numbers  ICMJE 331-13-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Director: Junichi Hashimoto, PhD Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP