Clinical trial NCT00905307: Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
Official title: A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients With Acute Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Relapsed
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
3. Subjects experiencing an acute exacerbation of psychotic symptoms

Exclusion Criteria:

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

   * Schizoaffective disorder
   * MDD
   * Bipolar disorder
   * Delirium, dementia, amnestic or other cognitive disorder
   * Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3. Subjects presenting with a first episode of schizophrenia
4. Other protocol specific inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)
timeFrame: Baseline to Week 6
measure: Mean Clinical Global Impression - Improvement (CGI-I) at Week 6
timeFrame: Week 6
measure: Response Rate at Week 6
timeFrame: Week 6
measure: Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Study Site
state: Arkansas
city: Escondido
country: United States
facility: Study Site
state: California
city: Garden Grove
country: United States
facility: Study Site
state: California
city: Long Beach
country: United States
facility: Study Site
state: California
city: Oceanside
country: United States
facility: Study Site
state: California
city: Pasadena
country: United States
facility: Study Site
state: California
city: San Diego
country: United States
facility: Study Site
state: California
city: San Diego
country: United States
facility: Study Site
state: California
city: Santa Ana
country: United States
facility: Study Site
state: California
city: Washington
country: United States
facility: Study Site
state: District of Columbia
city: Bradenton
country: United States
facility: Study Site
state: Florida
city: Maitland
country: United States
facility: Study Site
state: Florida
city: St. Louis
country: United States
facility: Study Site
state: Missouri
city: Cedarhurst
country: United States
facility: Study Site
state: New York
city: Philadelphia
country: United States
facility: Study Site
state: Pennsylvania
city: Austin
country: United States
facility: Study Site
state: Texas
city: Burgas
country: Bulgaria
facility: Study Site
city: Kazanlak
country: Bulgaria
facility: Study Site
city: Pazardzhik
country: Bulgaria
facility: Study Site
city: Plovdiv
country: Bulgaria
facility: Study Site
city: Radnevo
country: Bulgaria
facility: Study Site
city: Ruse
country: Bulgaria
facility: Study Site
city: Rijeka
country: Croatia
facility: Study Site
city: Split
country: Croatia
facility: Study Site
city: Zagreb
country: Croatia
facility: Study Site
city: Vijaywada
country: India
facility: Study Site
state: Andh Prad
city: Visakhapatnam
country: India
facility: Study Site
state: Andh Prad
city: Ahmedabad
country: India
facility: Study Site
state: Gujarat
city: Bangalore
country: India
facility: Study Site
state: Karna
city: Mangalore
country: India
facility: Study Site
state: Karna
city: Mangalore
country: India
facility: Study Site
state: Karna
city: Pune
country: India
facility: Study Site
state: Mahara
city: Chennai
country: India
facility: Study Site
state: Tamilnadu
city: Varanasi
country: India
facility: Study Site
state: Uttar Prad
city: Busan
country: Korea, Republic of
facility: Study Site
city: Chuncheon
country: Korea, Republic of
facility: Study Site
city: Incheon
country: Korea, Republic of
facility: Study Site
city: Incheon
country: Korea, Republic of
facility: Study Site
city: Seoul
country: Korea, Republic of
facility: Study Site
city: Cebu City 6000
country: Philippines
facility: Study Site
city: Mandaluyong City 1553
country: Philippines
facility: Study Site
city: Arad
country: Romania
facility: Study Site
city: Bucuresti
country: Romania
facility: Study Site
city: Bucuresti
country: Romania
facility: Study Site (1)
city: Bucuresti
country: Romania
facility: Study Site (2)
city: Bucuresti
country: Romania
facility: Study Site (3)
city: Cluj-Napoca
country: Romania
facility: Study Site
city: Oradea
country: Romania
facility: Study Site
city: Moscow Region
country: Russian Federation
facility: Study Site
city: Moscow
country: Russian Federation
facility: Study Site
city: Moscow
country: Russian Federation
facility: Study Site
city: St. Petersburg
country: Russian Federation
facility: Study Site
city: St. Petersburg
country: Russian Federation
facility: Study Site
city: St. Petersburg
country: Russian Federation
facility: Study Site
city: Belgrade
country: Serbia
facility: Study Site (1)
city: Belgrade
country: Serbia
facility: Study Site (2)
city: Kragujevac
country: Serbia
facility: Study Site
city: Novi Sad
country: Serbia
facility: Study Site
city: Bojnice
country: Slovakia
facility: Study Site
city: Bratislava
country: Slovakia
facility: Study Site
city: Liptovsky Mikulas
country: Slovakia
facility: Study Site
city: Rimavska Sobota
country: Slovakia
facility: Study Site
city: Zilina
country: Slovakia
facility: Study Site
city: Hualien Town
country: Taiwan
facility: Study Site
city: Taipei
country: Taiwan
facility: Study Site
city: Chernigiv
country: Ukraine
facility: Study Site
city: Dnipropetrovsk
country: Ukraine
facility: Study Site
city: Kherson,Vil. Stepanivka
country: Ukraine
facility: Study Site
city: Kyiv
country: Ukraine
facility: Study Site
city: Kyiv
country: Ukraine
facility: Study Site
city: Kyiv
country: Ukraine
facility: Study Site
city: Simferopol
country: Ukraine
facility: Study Site
city: Vinnitsia
country: Ukraine
facility: Study Site
Study officials:
References:
citation: Kane JM, Skuban A, Hobart M, Ouyang J, Weiller E, Weiss C, Correll CU. Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia. Schizophr Res. 2016 Jul;174(1-3):93-98. doi: 10.1016/j.schres.2016.04.013. Epub 2016 May 14.
citation: Citrome L. Brexpiprazole for schizophrenia and as adjunct for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antipsychotic - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int J Clin Pract. 2015 Sep;69(9):978-97. doi: 10.1111/ijcp.12714. Epub 2015 Aug 6.