search
Back to results

Brexpiprazole in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • US010
  • US020
  • US009
  • US022
  • US018
  • US011
  • US021
  • US004
  • US015
  • US019
  • US016
  • US002
  • US005
  • US003
  • US012
  • US001
  • US013
  • EE002
  • EE001
  • PL002
  • PL005
  • PL004
  • RO004
  • RO011
  • RO007
  • RO012
  • RO010
  • RO006
  • RU001
  • RU008
  • RU015
  • RU002
  • RU004
  • RU005
  • RU013
  • RS001
  • RS003
  • RS002
  • RS004
  • SK001
  • UA012
  • UA004
  • UA007
  • UA005
  • UA008
  • UA009
  • UA002
  • UA003

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brexpiprazole

Arm Description

Outcomes

Primary Outcome Measures

Safety and Tolerability
Number of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Full Information

First Posted
March 12, 2013
Last Updated
February 22, 2017
Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01810783
Brief Title
Brexpiprazole in Patients With Schizophrenia
Official Title
Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brexpiprazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
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 Measure Information:
Title
Safety and Tolerability
Description
Number of treatment-emergent adverse events (TEAEs)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US010
City
Anaheim
State/Province
California
Country
United States
Facility Name
US020
City
Cerritos
State/Province
California
Country
United States
Facility Name
US009
City
Escondido
State/Province
California
Country
United States
Facility Name
US022
City
Garden Grove
State/Province
California
Country
United States
Facility Name
US018
City
Long Beach
State/Province
California
Country
United States
Facility Name
US011
City
San Diego
State/Province
California
Country
United States
Facility Name
US021
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
US004
City
Kissimmee
State/Province
Florida
Country
United States
Facility Name
US015
City
North Miami
State/Province
Florida
Country
United States
Facility Name
US019
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
US016
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
US002
City
Cedarhurst
State/Province
New York
Country
United States
Facility Name
US005
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
US003
City
Austin
State/Province
Texas
Country
United States
Facility Name
US012
City
Austin
State/Province
Texas
Country
United States
Facility Name
US001
City
Dallas
State/Province
Texas
Country
United States
Facility Name
US013
City
Dallas
State/Province
Texas
Country
United States
Facility Name
EE002
City
Parnu
Country
Estonia
Facility Name
EE001
City
Tallinn
Country
Estonia
Facility Name
PL002
City
Choroszcz
Country
Poland
Facility Name
PL005
City
Choroszcz
Country
Poland
Facility Name
PL004
City
Gdansk
Country
Poland
Facility Name
RO004
City
Brasov
Country
Romania
Facility Name
RO011
City
Bucharest
Country
Romania
Facility Name
RO007
City
Bucuresti
Country
Romania
Facility Name
RO012
City
Bucuresti
Country
Romania
Facility Name
RO010
City
Iasi
Country
Romania
Facility Name
RO006
City
Pitesti
Country
Romania
Facility Name
RU001
City
Arkhangelsk
Country
Russian Federation
Facility Name
RU008
City
Moscow
Country
Russian Federation
Facility Name
RU015
City
Rostov on Don
Country
Russian Federation
Facility Name
RU002
City
Saratov
Country
Russian Federation
Facility Name
RU004
City
St. Petersburg
Country
Russian Federation
Facility Name
RU005
City
St. Petersburg
Country
Russian Federation
Facility Name
RU013
City
St. Petersburg
Country
Russian Federation
Facility Name
RS001
City
Belgrade
Country
Serbia
Facility Name
RS003
City
Belgrade
Country
Serbia
Facility Name
RS002
City
Kragujevac
Country
Serbia
Facility Name
RS004
City
Novi Knezevac
Country
Serbia
Facility Name
SK001
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
UA012
City
Dnipropetrovsk
Country
Ukraine
Facility Name
UA004
City
Geikivka
Country
Ukraine
Facility Name
UA007
City
Glevakha
Country
Ukraine
Facility Name
UA005
City
Kherson
Country
Ukraine
Facility Name
UA008
City
Kyiv
Country
Ukraine
Facility Name
UA009
City
Lviv
Country
Ukraine
Facility Name
UA002
City
Smila
Country
Ukraine
Facility Name
UA003
City
Vinnytsya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
35235720
Citation
Correll CU, He Y, Therrien F, MacKenzie E, Meehan SR, Weiss C, Hefting N, Hobart M. Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793.
Results Reference
derived
PubMed Identifier
34901863
Citation
Marder SR, Meehan SR, Weiss C, Chen D, Hobart M, Hefting N. Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan.
Results Reference
derived

Learn more about this trial

Brexpiprazole in Patients With Schizophrenia

We'll reach out to this number within 24 hrs