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Brexpiprazole in Patients With Schizophrenia

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: NCT01810783
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : February 23, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE March 12, 2013
First Posted Date  ICMJE March 14, 2013
Results First Submitted Date  ICMJE December 30, 2016
Results First Posted Date  ICMJE February 23, 2017
Last Update Posted Date March 27, 2017
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
Safety and Tolerability [ Time Frame: Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP) ]
Number of treatment-emergent adverse events (TEAEs)
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
  • Safety and Tolerability [ Time Frame: Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP) ]
    Number of adverse events
  • Risk of suicidality [ Time Frame: Up to 52 weeks ]
    Columbia-Suicide Severity Rating Scale (C-SSRS) score
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
  • Change from baseline in psychotic symptoms [ Time Frame: Baseline and Week 52 ]
    Positive and Negative Syndrome Scale (PANSS) total score
  • Change from baseline in psychotic symptoms [ Time Frame: Baseline and Week 52 ]
    PANSS Positive Subscale score
  • Change from baseline in psychotic symptoms [ Time Frame: Baseline and Week 52 ]
    PANSS Negative Subscale score
  • Change from baseline in psychotic symptoms [ Time Frame: Baseline and Week 52 ]
    PANSS Excited Component score
  • Change from baseline in psychotic symptoms [ Time Frame: Baseline and Week 52 ]
    PANSS Marder score
  • Change from baseline in clinical global impression [ Time Frame: Baseline and Week 52 ]
    Clinical Global Impression - Severity of Illness (CGI-S) score
  • Improvement of clinical global impression [ Time Frame: Week 52 ]
    Clinical Global Impression - Global Improvement (CGI-I) score
  • Response rate [ Time Frame: Baseline and Week 52 ]
    Based on pre-specified decrease in PANSS total score or CGI-I score
  • Change from baseline in personal and social performance [ Time Frame: Baseline and Week 52 ]
    Personal and Social Performance scale (PSP)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brexpiprazole in Patients With Schizophrenia
Official Title  ICMJE Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
Brief Summary To determine the safety and efficacy of brexpiprazole during long-term treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Brexpiprazole
1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Study Arms  ICMJE Experimental: Brexpiprazole
Intervention: Drug: Brexpiprazole
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: January 18, 2016)
210
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2013)
140
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient has completed the lead-in study 14644A.
  • The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
  • The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

  • The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A.
  • The patient has a clinically significant unstable illness diagnosed during Study 14644A.
  • The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
  • The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
  • The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.

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 Estonia,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01810783
Other Study ID Numbers  ICMJE 14644B
2012-002705-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date February 2017

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