Clinical trial NCT01810783: Brexpiprazole in Patients With Schizophrenia
Official title: Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-03-14
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: US010
state: California
city: Cerritos
country: United States
facility: US020
state: California
city: Escondido
country: United States
facility: US009
state: California
city: Garden Grove
country: United States
facility: US022
state: California
city: Long Beach
country: United States
facility: US018
state: California
city: San Diego
country: United States
facility: US011
state: California
city: Washington
country: United States
facility: US021
state: District of Columbia
city: Kissimmee
country: United States
facility: US004
state: Florida
city: North Miami
country: United States
facility: US015
state: Florida
city: Lake Charles
country: United States
facility: US019
state: Louisiana
city: St. Louis
country: United States
facility: US016
state: Missouri
city: Cedarhurst
country: United States
facility: US002
state: New York
city: Charleston
country: United States
facility: US005
state: South Carolina
city: Austin
country: United States
facility: US003
state: Texas
city: Austin
country: United States
facility: US012
state: Texas
city: Dallas
country: United States
facility: US001
state: Texas
city: Dallas
country: United States
facility: US013
state: Texas
city: Parnu
country: Estonia
facility: EE002
city: Tallinn
country: Estonia
facility: EE001
city: Choroszcz
country: Poland
facility: PL002
city: Choroszcz
country: Poland
facility: PL005
city: Gdansk
country: Poland
facility: PL004
city: Brasov
country: Romania
facility: RO004
city: Bucharest
country: Romania
facility: RO011
city: Bucuresti
country: Romania
facility: RO007
city: Bucuresti
country: Romania
facility: RO012
city: Iasi
country: Romania
facility: RO010
city: Pitesti
country: Romania
facility: RO006
city: Arkhangelsk
country: Russian Federation
facility: RU001
city: Moscow
country: Russian Federation
facility: RU008
city: Rostov on Don
country: Russian Federation
facility: RU015
city: Saratov
country: Russian Federation
facility: RU002
city: St. Petersburg
country: Russian Federation
facility: RU004
city: St. Petersburg
country: Russian Federation
facility: RU005
city: St. Petersburg
country: Russian Federation
facility: RU013
city: Belgrade
country: Serbia
facility: RS001
city: Belgrade
country: Serbia
facility: RS003
city: Kragujevac
country: Serbia
facility: RS002
city: Novi Knezevac
country: Serbia
facility: RS004
city: Liptovsky Mikulas
country: Slovakia
facility: SK001
city: Dnipropetrovsk
country: Ukraine
facility: UA012
city: Geikivka
country: Ukraine
facility: UA004
city: Glevakha
country: Ukraine
facility: UA007
city: Kherson
country: Ukraine
facility: UA005
city: Kyiv
country: Ukraine
facility: UA008
city: Lviv
country: Ukraine
facility: UA009
city: Smila
country: Ukraine
facility: UA002
city: Vinnytsya
country: Ukraine
facility: UA003
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
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.
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.