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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

Brief Summary:
To determine the safety and efficacy of brexpiprazole during long-term treatment.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Brexpiprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
Study Start Date : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Brexpiprazole 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).




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810783


  Show 48 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01810783     History of Changes
Other Study ID Numbers: 14644B
2012-002705-21 ( EudraCT Number )
First Posted: March 14, 2013    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: March 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents