Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia

NCT ID: NCT01397786

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1044 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-01-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPC-34712

Group Type: EXPERIMENTAL

OPC-34712

Intervention Type: DRUG

Phase A: 1-2 mgs/day by mouth, max of 4 wks.

Phase B: 1-4 mgs/day by mouth, up to 52 weeks

Interventions

OPC-34712

Phase A: 1-2 mgs/day by mouth, max of 4 wks.

Phase B: 1-4 mgs/day by mouth, up to 52 weeks

Intervention Type: DRUG

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksandar Skuban, M.D.

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

Birmingham, Alabama, United States

Little Rock, Arkansas, United States

Little Rock, Arkansas, United States

Springdale, Arkansas, United States

Anaheim, California, United States

Cerritos, California, United States

Escondido, California, United States

Garden Grove, California, United States

Glendale, California, United States

Long Beach, California, United States

National City, California, United States

Oakland, California, United States

Oceanside, California, United States

Pico Rivera, California, United States

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

Torrance, California, United States

Washington D.C., District of Columbia, United States

Bradenton, Florida, United States

Leesburg, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

Miami Springs, Florida, United States

North Miami, Florida, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Hoffman Estates, Illinois, United States

Joliet, Illinois, United States

Oak Brook, Illinois, United States

Overland Park, Kansas, United States

Lake Charles, Louisiana, United States

Shreveport, Louisiana, United States

Flowood, Mississippi, United States

Saint Charles, Missouri, United States

St Louis, Missouri, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

Buffalo, New York, United States

Cedarhurst, New York, United States

Jamaica, New York, United States

Rochester, New York, United States

Staten Island, New York, United States

Staten Island, New York, United States

Dayton, Ohio, United States

Allentown, Pennsylvania, United States

Norristown, Pennsylvania, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Austin, Texas, United States

Austin, Texas, United States

Dallas, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Richmond, Virginia, United States

Kirkland, Washington, United States

Burlington, Ontario, Canada

Chatham, Ontario, Canada

Barranquilla, , Colombia

Bello, , Colombia

Bogotá, , Colombia

Pereira, , Colombia

Rijeka, , Croatia

Zagreb, , Croatia

Fujisawa-shi, Kanagawa, Japan

Kumamoto, Kumamoto, Japan

Kunigami-gun, Okinawa, Japan

Sakai-shi, Osaka, Japan

Daugavpils, , Latvia

Jelgava, , Latvia

Liepāja, , Latvia

Riga, , Latvia

Strenči, , Latvia

Kota Bharu, Kelantan, Malaysia

Kuala Lumpur, Kuala Lumpur, Malaysia

Kajang, Selangor, Malaysia

Ipoh, , Malaysia

Jalan Greentown, , Malaysia

Sabak Bernam, , Malaysia

Col. Florida, Mexico City, Mexico

Monterrey, Nuevo León, Mexico

San Luis Potosí City, San Luis Potos, Mexico

Cebu City, , Philippines

Davao City, , Philippines

Manila, , Philippines

Choroszcz, , Poland

Gdansk, , Poland

Gdansk, , Poland

Lodz, , Poland

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Arad, , Romania

Brasov, , Romania

Bucharest, , Romania

Bucharest, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Craiova, , Romania

Focşani, , Romania

Iași, , Romania

Piteşti, , Romania

Târgovişte, , Romania

Arkhangelsk, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow Region, , Russia

Nizhny Novgorod, , Russia

Petrozavodsk, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Saratov, , Russia

Tomsk, , Russia

Village Nikolskoe, , Russia

Belgrade, , Serbia

Kragujevac, , Serbia

Novi Kneževac, , Serbia

Novi Sad, , Serbia

Bratislava, , Slovakia

Michalovce, , Slovakia

Rimavská Sobota, , Slovakia

Rožňava, , Slovakia

Incheon, , South Korea

Incheon, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Kashsiung, , Taiwan

New Taipei City, , Taiwan

Taipei, , Taiwan

Taoyuan, , Taiwan

Diyarbakır, , Turkey (Türkiye)

Kocaeli, , Turkey (Türkiye)

Chernihiv, , Ukraine

Dnipropetrovsk, , Ukraine

Dnipropetrovsk, , Ukraine

Hlevakha, , Ukraine

Kharkiv, , Ukraine

Kherson, Vil. Stepanivka, , Ukraine

Kyiv, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Simferopol, , Ukraine

Vinnytsia, , Ukraine

Countries

United States; Canada; Colombia; Croatia; Japan; Latvia; Malaysia; Mexico; Philippines; Poland; Puerto Rico; Romania; Russia; Serbia; Slovakia; South Korea; Taiwan; Turkey (Türkiye); Ukraine

References

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.

Reference Type: DERIVED

PMID: 35235720 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34901863 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29985680 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29415258 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27188270 (View on PubMed)

Other Identifiers

331-10-237

Identifier Type: -

Identifier Source: org_study_id