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Trial record 1 of 1 for:    NCT01810783
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Brexpiprazole in Patients With Schizophrenia

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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

March 12, 2013
March 14, 2013
December 30, 2016
February 23, 2017
March 27, 2017
July 2013
December 2015   (Final data collection date for primary outcome measure)
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)
  • 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
Complete list of historical versions of study NCT01810783 on ClinicalTrials.gov Archive Site
Not Provided
  • 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)
Not Provided
Not Provided
 
Brexpiprazole in Patients With Schizophrenia
Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
To determine the safety and efficacy of brexpiprazole during long-term treatment.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
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).
Experimental: Brexpiprazole
Intervention: Drug: Brexpiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
140
December 2015
December 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Estonia,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Ukraine,   United States
 
 
NCT01810783
14644B
2012-002705-21 ( EudraCT Number )
No
Not Provided
Not Provided
H. Lundbeck A/S
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
February 2017

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