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Brexpiprazole in Patients With Acute Schizophrenia

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ClinicalTrials.gov Identifier: NCT01810380
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : March 29, 2016
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Placebo
Drug: Brexpiprazole
Drug: Quetiapine extended release

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo: Once daily as tablets and capsules, orally
Brexpiprazole Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
Quetiapine Extended Release

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally


Participant Flow:   Overall Study
    Placebo   Brexpiprazole   Quetiapine Extended Release
STARTED   163   151   154 
Treated   161   150   153 
COMPLETED   108   113   122 
NOT COMPLETED   55   38   32 
Randomised not treated                2                1                1 
Adverse Event                11                14                4 
Lack of Efficacy                24                10                11 
Protocol Violation                1                0                1 
Withdrawal by Subject                6                0                6 
Administrative or other reasons                11                13                9 



  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.
all-patients-treated set (APTS)

Reporting Groups
  Description
Placebo Placebo: Once daily as tablets and capsules, orally
Brexpiprazole Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
Quetiapine Extended Release

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Total Total of all reporting groups

Baseline Measures
   Placebo   Brexpiprazole   Quetiapine Extended Release   Total 
Overall Participants Analyzed 
[Units: Participants]
 161   150   153   464 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.85  (10.56)   39.68  (10.87)   41.12  (10.91)   40.56  (10.77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      70  43.5%      66  44.0%      64  41.8%      200  43.1% 
Male      91  56.5%      84  56.0%      89  58.2%      264  56.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      1   0.7%      0   0.0%      1   0.2% 
Asian      2   1.2%      1   0.7%      0   0.0%      3   0.6% 
Native Hawaiian or Other Pacific Islander      1   0.6%      0   0.0%      1   0.7%      2   0.4% 
Black or African American      35  21.7%      33  22.0%      38  24.8%      106  22.8% 
White      123  76.4%      113  75.3%      113  73.9%      349  75.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      2   1.3%      1   0.7%      3   0.6% 
Region of Enrollment 
[Units: Participants]
       
United States   50   52   56   158 
Estonia   4   3   4   11 
France   1   0   1   2 
Poland   5   5   5   15 
Romania   14   13   11   38 
Serbia   13   11   11   35 
Slovakia   1   1   1   3 
Ukraine   30   28   29   87 
Russian Federation   43   37   35   115 
Time since schizophrenia diagnosis (years) 
[Units: Years]
Mean (Standard Deviation)
 14.15  (9.35)   12.88  (9.43)   13.78  (9.49)   13.62  (9.42) 
Time since first antipsychotic treatment (years) 
[Units: Years]
Mean (Standard Deviation)
 14.48  (8.98)   13.43  (9.19)   14.31  (9.34)   14.08  (9.16) 
PANSS total score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 98.38  (10.30)   97.82  (10.25)   98.82  (10.83)   98.34  (10.45) 
[1] The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. PANSS total score is reported for the full analysis set (FAS); PBO=159, Brex=150, Que=150, and no total value was summarised for reporting
CGI-S Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.94  (0.57)   4.96  (0.59)   4.98  (0.57)   4.96  (0.58) 
[1] The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). CGI-S score is reported for the full analysis set (FAS); PBO=159, Brex=150, Que=150, and no total value was summarised for reporting


  Outcome Measures

1.  Primary:   Change From Baseline to Week 6 in PANSS Total Score   [ Time Frame: Baseline and Week 6 ]

2.  Secondary:   Change From Baseline to Week 6 in CGI-S Score   [ Time Frame: Baseline and Week 6 ]

3.  Secondary:   CGI-I Score at Week 6   [ Time Frame: Week 6 ]

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

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

6.  Secondary:   Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score   [ Time Frame: Baseline and Week 6 ]

7.  Secondary:   Change From Baseline to Week 6 in PANSS Excited Component Score   [ Time Frame: Baseline and Week 6 ]

8.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms   [ Time Frame: Baseline and Week 6 ]

9.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms   [ Time Frame: Baseline and Week 6 ]

10.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts   [ Time Frame: Baseline and Week 6 ]

11.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement   [ Time Frame: Baseline and Week 6 ]

12.  Secondary:   Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression   [ Time Frame: Baseline and Week 6 ]

13.  Secondary:   Discontinuation Due to Lack of Efficacy During the Study   [ Time Frame: Baseline to Week 6 ]

14.  Secondary:   Response Rate at Week 6   [ Time Frame: Baseline and Week 6 ]

15.  Secondary:   Change From Baseline to Week 6 in PSP Total Score   [ Time Frame: Baseline and Week 6 ]

16.  Secondary:   PSP Functional Remission Rate at Week 6   [ Time Frame: Week 6 ]

17.  Secondary:   PSP Functional Response Rate at Week 6   [ Time Frame: Week 6 ]

18.  Secondary:   PSP Domain D: Disturbing and Aggressive Behaviours at Week 6   [ Time Frame: 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: Email contact via
Organization: H. Lundbeck A/S
e-mail: LundbeckClinicalTrials@Lundbeck.com



Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01810380     History of Changes
Other Study ID Numbers: 14644A
2012-002252-17 ( EudraCT Number )
First Submitted: March 11, 2013
First Posted: March 13, 2013
Results First Submitted: December 30, 2015
Results First Posted: March 29, 2016
Last Update Posted: March 16, 2017