Brexpiprazole in Patients With Schizophrenia
- Registration Number
- NCT01810783
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
To determine the safety and efficacy of brexpiprazole during long-term treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brexpiprazole Brexpiprazole -
- Primary Outcome Measures
Name Time Method Safety and Tolerability 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
US004
🇺🇸Kissimmee, Florida, United States
US013
🇺🇸Dallas, Texas, United States
UA009
🇺🇦Lviv, Ukraine
UA003
🇺🇦Vinnytsya, Ukraine
RU013
🇷🇺St. Petersburg, Russian Federation
US010
🇺🇸Anaheim, California, United States
US009
🇺🇸Escondido, California, United States
US001
🇺🇸Dallas, Texas, United States
US015
🇺🇸North Miami, Florida, United States
EE002
🇪🇪Parnu, Estonia
RO011
🇷🇴Bucharest, Romania
PL005
🇵🇱Choroszcz, Poland
PL004
🇵🇱Gdansk, Poland
US021
🇺🇸Washington, District of Columbia, United States
US020
🇺🇸Cerritos, California, United States
US019
🇺🇸Lake Charles, Louisiana, United States
PL002
🇵🇱Choroszcz, Poland
US018
🇺🇸Long Beach, California, United States
US022
🇺🇸Garden Grove, California, United States
US002
🇺🇸Cedarhurst, New York, United States
US016
🇺🇸St. Louis, Missouri, United States
EE001
🇪🇪Tallinn, Estonia
RO004
🇷🇴Brasov, Romania
RO007
🇷🇴Bucuresti, Romania
RO012
🇷🇴Bucuresti, Romania
RO006
🇷🇴Pitesti, Romania
RO010
🇷🇴Iasi, Romania
RU008
🇷🇺Moscow, Russian Federation
RU001
🇷🇺Arkhangelsk, Russian Federation
RU015
🇷🇺Rostov on Don, Russian Federation
RU005
🇷🇺St. Petersburg, Russian Federation
RU004
🇷🇺St. Petersburg, Russian Federation
RU002
🇷🇺Saratov, Russian Federation
SK001
🇸🇰Liptovsky Mikulas, Slovakia
RS001
🇷🇸Belgrade, Serbia
RS004
🇷🇸Novi Knezevac, Serbia
RS003
🇷🇸Belgrade, Serbia
UA012
🇺🇦Dnipropetrovsk, Ukraine
UA004
🇺🇦Geikivka, Ukraine
UA007
🇺🇦Glevakha, Ukraine
UA008
🇺🇦Kyiv, Ukraine
RS002
🇷🇸Kragujevac, Serbia
UA005
🇺🇦Kherson, Ukraine
UA002
🇺🇦Smila, Ukraine
US012
🇺🇸Austin, Texas, United States
US011
🇺🇸San Diego, California, United States
US005
🇺🇸Charleston, South Carolina, United States
US003
🇺🇸Austin, Texas, United States