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Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia (VECTOR)

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ClinicalTrials.gov Identifier: NCT01396421
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : October 29, 2015
Last Update Posted : October 29, 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 [Brexpiprazole] High Dose
Drug: Experimental: OPC-34712 [Brexpiprazole] Middle Dose
Drug: Experimental: OPC-34712 [Brexpiprazole] Low Dose
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
The trial was conducted in 636 participants from 65 trial sites in 10 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 for schizophrenia and psychotic disorders studies.

Reporting Groups
  Description
Brexpiprazole 4 mg

Brexpiprazole 4 milligram (mg) tablet once daily for 6 weeks.

Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).

Brexpiprazole 2mg

Brexpiprazole 2mg tablet once daily for 6 weeks.

Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5.

Brexpiprazole 0.25mg Brexpiprazole 0.25mg tablet once daily for 6 weeks.
Placebo Placebo tablet once daily for 6 weeks.

Participant Flow:   Overall Study
    Brexpiprazole 4 mg   Brexpiprazole 2mg   Brexpiprazole 0.25mg   Placebo
STARTED   180   182   90   184 
COMPLETED   121   124   56   109 
NOT COMPLETED   59   58   34   75 
Lost to Follow-up                0                0                0                1 
Adverse Event                17                15                12                32 
Participant Met Withdrawal Criteria                1                0                1                0 
Physician Decision                1                1                0                3 
Withdrawal by Subject                31                24                13                21 
Protocol Deviation                2                1                1                0 
Lack of Efficacy                7                17                7                18 



  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 4mg

Brexpiprazole 4mg tablet once daily for 6 weeks.

Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).

Brexpiprazole 2mg

Brexpiprazole 2mg tablet once daily for 6 weeks.

Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5.

Brexpiprazole 0.25 mg Brexpiprazole 0.25mg tablet once daily for 6 weeks.
Placebo Placebo tablet once daily for 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Brexpiprazole 4mg   Brexpiprazole 2mg   Brexpiprazole 0.25 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 180   182   90   184   636 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.8  (11.0)   39.6  (10.2)   40.5  (11.4)   39.7  (10.8)   40.1  (10.8) 
Gender 
[Units: Participants]
         
Female   69   71   29   66   235 
Male   111   111   61   118   401 


  Outcome Measures

1.  Primary:   Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.   [ Time Frame: Baseline to Week 6 ]

2.  Secondary:   Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.   [ Time Frame: Baseline to Week 6 ]

3.  Secondary:   Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.   [ Time Frame: Baseline to Week 1, 2, 3, 4, 5 ]

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

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

6.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score   [ Time Frame: Baseline to Week 6 ]

7.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score   [ Time Frame: Baseline to Week 6 ]

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

9.  Secondary:   Response Rate at Week 6   [ Time Frame: Week 6 ]

10.  Secondary:   Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score   [ Time Frame: Baseline to Week 6 ]

11.  Secondary:   Discontinuation Rate for Lack of Efficacy at Week 6   [ Time Frame: Week 6 ]

12.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score   [ Time Frame: Baseline to Week 6 ]

13.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score   [ Time Frame: Baseline to Week 6 ]

14.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score   [ Time Frame: Baseline to Week 6 ]

15.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score   [ Time Frame: Baseline to Week 6 ]

16.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score   [ Time Frame: Baseline to Week 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 & 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: NCT01396421     History of Changes
Other Study ID Numbers: 331-10-231
First Submitted: July 11, 2011
First Posted: July 18, 2011
Results First Submitted: August 4, 2015
Results First Posted: October 29, 2015
Last Update Posted: October 29, 2015