Brexpiprazole in Patients With Schizophrenia
Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
2 other identifiers
interventional
210
8 countries
48
Brief Summary
To determine the safety and efficacy of brexpiprazole during long-term treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Jul 2013
Typical duration for phase_3 schizophrenia
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedMarch 27, 2017
February 1, 2017
2.4 years
March 12, 2013
December 30, 2016
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability
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)
Study Arms (1)
Brexpiprazole
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
- Otsuka Pharmaceutical Co., Ltd.collaborator
Study Sites (48)
US010
Anaheim, California, United States
US020
Cerritos, California, United States
US009
Escondido, California, United States
US022
Garden Grove, California, United States
US018
Long Beach, California, United States
US011
San Diego, California, United States
US021
Washington D.C., District of Columbia, United States
US004
Kissimmee, Florida, United States
US015
North Miami, Florida, United States
US019
Lake Charles, Louisiana, United States
US016
St Louis, Missouri, United States
US002
Cedarhurst, New York, United States
US005
Charleston, South Carolina, United States
US003
Austin, Texas, United States
US012
Austin, Texas, United States
US001
Dallas, Texas, United States
US013
Dallas, Texas, United States
EE002
Pärnu, Estonia
EE001
Tallinn, Estonia
PL002
Choroszcz, Poland
PL005
Choroszcz, Poland
PL004
Gdansk, Poland
RO004
Brasov, Romania
RO007
Bucharest, Romania
RO011
Bucharest, Romania
RO012
Bucharest, Romania
RO010
Iași, Romania
RO006
Piteşti, Romania
RU001
Arkhangelsk, Russia
RU008
Moscow, Russia
RU015
Rostov-on-Don, Russia
RU004
Saint Petersburg, Russia
RU005
Saint Petersburg, Russia
RU013
Saint Petersburg, Russia
RU002
Saratov, Russia
RS001
Belgrade, Serbia
RS003
Belgrade, Serbia
RS002
Kragujevac, Serbia
RS004
Novi Kneževac, Serbia
SK001
Liptovský Mikuláš, Slovakia
UA012
Dnipropetrovsk, Ukraine
UA004
Geikivka, Ukraine
UA007
Hlevakha, Ukraine
UA005
Kherson, Ukraine
UA008
Kyiv, Ukraine
UA009
Lviv, Ukraine
UA002
Smila, Ukraine
UA003
Vinnytsia, Ukraine
Related Publications (2)
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.
PMID: 35235720DERIVEDMarder 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.
PMID: 34901863DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Email contact via
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 14, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 27, 2017
Results First Posted
February 23, 2017
Record last verified: 2017-02