ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01393613
Previous Study | Return to List | Next Study

Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia (BEACON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01393613
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : November 26, 2015
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Schizophrenia
Interventions: Drug: OPC-34712
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was conducted in 674 participants from 68 trial sites in 8 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Adults with schizophrenia as defined by Diagnostic and Statistical Manual of Mental Health Disorders 4th Edition Text Revision criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) for schizophrenia and psychotic disorders studies were included.

Reporting Groups
  Description
Brexpiprazole 1 mg Brexpiprazole 1 mg tablet once daily for 6 weeks.
Brexpiprazole 2 mg Brexpiprazole 2 mg tablet once daily for 6 weeks.
Brexpiprazole 4 mg Brexpiprazole 4 mg tablet once daily for 6 weeks.
Placebo Placebo tablet once daily for 6 weeks.

Participant Flow:   Overall Study
    Brexpiprazole 1 mg   Brexpiprazole 2 mg   Brexpiprazole 4 mg   Placebo
STARTED   120   186   184   184 
COMPLETED   81   129   130   118 
NOT COMPLETED   39   57   54   66 
Adverse Event                11                11                13                22 
Participant Met Withdrawal Criteria                0                0                2                1 
Physician Decision                2                0                0                1 
Withdrawal by Subject                15                25                23                21 
Protocol Deviation                2                1                0                0 
Lack of Efficacy                9                20                16                21 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Brexpiprazole 1 mg Brexpiprazole 1 mg tablet once daily for 6 weeks.
Brexpiprazole 2 mg Brexpiprazole 2 mg tablet once daily for 6 weeks.
Brexpiprazole 4 mg Brexpiprazole 4 mg tablet once daily for 6 weeks.
Placebo Placebo tablet once daily for 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Brexpiprazole 1 mg   Brexpiprazole 2 mg   Brexpiprazole 4 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   186   184   184   674 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.1  (11.9)   36.9  (10.9)   38.6  (11.0)   39.3  (10.8)   38.4  (11.1) 
Gender 
[Units: Participants]
         
Female   43   64   71   73   251 
Male   77   122   113   111   423 


  Outcome Measures

1.  Primary:   Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Measure Description 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).
Time Frame Baseline, Weeks 1, 2, 3, 4, 5, and 6  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.

Reporting Groups
  Description
Brexpiprazole 1 mg Brexpiprazole 1 mg tablet once daily for 6 weeks.
Brexpiprazole 2 mg Brexpiprazole 2 mg tablet once daily for 6 weeks.
Brexpiprazole 4 mg Brexpiprazole 4 mg tablet once daily for 6 weeks.
Placebo Placebo tablet once daily for 6 weeks.

Measured Values
   Brexpiprazole 1 mg   Brexpiprazole 2 mg   Brexpiprazole 4 mg   Placebo 
Participants Analyzed   117   179   181   180 
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score. 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
       
Week 1   -3.32  (0.83)   -4.35  (0.68)   -5.58  (0.68)   -3.48  (0.68) 
Week 2   -7.61  (1.09)   -8.70  (0.88)   -8.42  (0.88)   -6.61  (0.89) 
Week 3   -11.56  (1.30)   -10.69  (1.06)   -12.63  (1.05)   -8.95  (1.06) 
Week 4   -13.97  (1.49)   -13.12  (1.21)   -15.55  (1.19)   -11.10  (1.22) 
Week 5   -14.47  (1.71)   -14.11  (1.38)   -17.26  (1.37)   -11.89  (1.40) 
Week 6   -16.90  (1.86)   -16.61  (1.49)   -20.00  (1.48)   -13.53  (1.52) 


Statistical Analysis 1 for Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Groups [1] Brexpiprazole 2 mg vs. Brexpiprazole 4 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.0093
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6. The primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) with an unstructured variance covariance structure. The model included fixed class effect terms for treatment, trial site, visit week, baseline, baseline and visit interaction and an interaction term of treatment by visit week.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Groups [1] Brexpiprazole 4 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.0022
Mean Difference (Final Values) [5] -6.47
95% Confidence Interval -10.6 to -2.35
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Groups [1] Brexpiprazole 2 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.1448
Mean Difference (Final Values) [5] -3.08
95% Confidence Interval -7.23 to 1.07
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.
Groups [1] Brexpiprazole 1 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.1588
Mean Difference (Final Values) [5] -3.37
95% Confidence Interval -8.06 to 1.32
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6. MMRM analysis fixed effect of treatment, clinical visit, trial site, treatment visit interaction, Baseline value, and Baseline visit interaction as covariates.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



2.  Secondary:   Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]

3.  Secondary:   Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.   [ Time Frame: Baseline, Week 3 and Week 6 ]

4.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]

5.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]

6.  Secondary:   Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.   [ Time Frame: Week 6 ]

7.  Secondary:   Percentage of Participants With Response at Week 6.   [ Time Frame: Week 6 ]

8.  Secondary:   Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6.   [ Time Frame: Week 6 ]

9.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]

10.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]

11.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]

12.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]

13.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]

14.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, and 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
phone: 800 562-3974


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01393613     History of Changes
Other Study ID Numbers: 331-10-230
First Submitted: July 11, 2011
First Posted: July 13, 2011
Results First Submitted: August 11, 2015
Results First Posted: November 26, 2015
Last Update Posted: November 26, 2015