Brexpiprazole in Patients With Schizophrenia

February 22, 2017 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Parnu, Estonia
        • EE002
      • Tallinn, Estonia
        • EE001
  • Poland
      • Choroszcz, Poland
        • PL002
      • Choroszcz, Poland
        • PL005
      • Gdansk, Poland
        • PL004
  • Romania
      • Brasov, Romania
        • RO004
      • Bucharest, Romania
        • RO011
      • Bucuresti, Romania
        • RO007
      • Bucuresti, Romania
        • RO012
      • Iasi, Romania
        • RO010
      • Pitesti, Romania
        • RO006
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • RU001
      • Moscow, Russian Federation
        • RU008
      • Rostov on Don, Russian Federation
        • RU015
      • Saratov, Russian Federation
        • RU002
      • St. Petersburg, Russian Federation
        • RU004
      • St. Petersburg, Russian Federation
        • RU005
      • St. Petersburg, Russian Federation
        • RU013
  • Serbia
      • Belgrade, Serbia
        • RS003
      • Belgrade, Serbia
        • RS001
      • Kragujevac, Serbia
        • RS002
      • Novi Knezevac, Serbia
        • RS004
  • Slovakia
      • Liptovsky Mikulas, Slovakia
        • SK001
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • UA012
      • Geikivka, Ukraine
        • UA004
      • Glevakha, Ukraine
        • UA007
      • Kherson, Ukraine
        • UA005
      • Kyiv, Ukraine
        • UA008
      • Lviv, Ukraine
        • UA009
      • Smila, Ukraine
        • UA002
      • Vinnytsya, Ukraine
        • UA003
  • United States
    • California
      • Anaheim, California, United States
        • US010
      • Cerritos, California, United States
        • US020
      • Escondido, California, United States
        • US009
      • Garden Grove, California, United States
        • US022
      • Long Beach, California, United States
        • US018
      • San Diego, California, United States
        • US011
    • District of Columbia
      • Washington, District of Columbia, United States
        • US021
    • Florida
      • Kissimmee, Florida, United States
        • US004
      • North Miami, Florida, United States
        • US015
    • Louisiana
      • Lake Charles, Louisiana, United States
        • US019
    • Missouri
      • St. Louis, Missouri, United States
        • US016
    • New York
      • Cedarhurst, New York, United States
        • US002
    • South Carolina
      • Charleston, South Carolina, United States
        • US005
    • Texas
      • Austin, Texas, United States
        • US003
      • Austin, Texas, United States
        • US012
      • Dallas, Texas, United States
        • US001
      • Dallas, Texas, United States
        • US013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14644B
  • 2012-002705-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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