Clinical trial NCT01397786: Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Official title: A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 1044
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: The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.

Detailed description: Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

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. Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
3. Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
4. Other protocol specific inclusion criteria may apply.

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 exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: From Baseline up to 52 Weeks
Secondary outcomes:
measure: Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in PANSS Positive Subscale Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in PANSS Negative Subscale Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in Personal and Social Performance Scale Total Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Clinical Global Impression - Improvement Score
timeFrame: From Baseline up to 52 Weeks
measure: Response Rate
timeFrame: From Baseline up to 52 Weeks
measure: Discontinuation Rate for Lack of Efficacy
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score
timeFrame: From Baseline up to 52 Weeks
measure: Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score
timeFrame: From Baseline up to 52 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Springdale
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Escondido
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Long Beach
country: United States
state: California
city: National City
country: United States
state: California
city: Oakland
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: LeesBurg
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Miami Springs
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Oak Brook
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Lake Charles
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Flowood
country: United States
state: Mississippi
city: St. Charles
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Buffalo
country: United States
state: New York
city: Cedarhurst
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
city: Burlington
country: Canada
state: Ontario
city: Chatham
country: Canada
state: Ontario
city: Barranquilla
country: Colombia
city: Bello
country: Colombia
city: Bogota
country: Colombia
city: Pereira
country: Colombia
city: Rijeka
country: Croatia
city: Zagreb
country: Croatia
city: Fujisawa-shi
country: Japan
state: Kanagawa-Ken
city: Kumamoto-shi
country: Japan
state: Kumamoto-Ken
city: Kunigami-gun
country: Japan
state: Okinawa-Ken
city: Sakai-shi
country: Japan
state: Osaka-Fu
city: Incheon
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Daugavpils
country: Latvia
city: Jelgava
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Strenci
country: Latvia
city: Kota Bahru
country: Malaysia
state: Kelantan
city: Kajang
country: Malaysia
state: Selangor
city: Ipoh
country: Malaysia
city: Jalan Greentown
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Sabah
country: Malaysia
city: Col. Florida
country: Mexico
state: Distrito Federal
city: Monterrey
country: Mexico
state: Nuevo Leon
city: San Luis Potosi
country: Mexico
state: San Luis Potos
city: Cebu City
country: Philippines
city: Davao City
country: Philippines
city: Manila
country: Philippines
city: Choroszcz
country: Poland
city: Gdansk
country: Poland
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Arad
country: Romania
city: Brasov
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Focsani
country: Romania
city: Iasi
country: Romania
city: Pitesti
country: Romania
city: Targoviste
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Moscow Region
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Village Nikolskoe
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Novi Knezevac
country: Serbia
city: Novi Sad
country: Serbia
city: Bratislava
country: Slovakia
city: Michalovce
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Roznava
country: Slovakia
city: Kashsiung
country: Taiwan
city: New Taipei City
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan County
country: Taiwan
city: Diyarbakir
country: Turkey
city: Kocaeli
country: Turkey
city: Chernihiv
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Glevakha
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson, Vil. Stepanivka
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odesa
country: Ukraine
city: Simferopol
country: Ukraine
city: Vinnytsia
country: Ukraine
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Aleksandar Skuban, M.D.
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.
citation: Newcomer JW, Eriksson H, Zhang P, Weiller E, Weiss C. Changes in metabolic parameters and body weight in brexpiprazole-treated patients with acute schizophrenia: pooled analyses of phase 3 clinical studies. Curr Med Res Opin. 2018 Dec;34(12):2197-2205. doi: 10.1080/03007995.2018.1498779. Epub 2018 Jul 27.
citation: Forbes A, Hobart M, Ouyang J, Shi L, Pfister S, Hakala M. A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia. Int J Neuropsychopharmacol. 2018 May 1;21(5):433-441. doi: 10.1093/ijnp/pyy002.
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.