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

NCT01397786 | Completed Phase 3 Results

• 1 other identifier: 331-10-237
• Study Type: interventional
• Target: 1,044
• Locations: 19 countries
• Sites: 148

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.

  From Baseline up to 52 Weeks

Secondary Outcomes (14)

• Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score

  From Baseline up to 52 Weeks

• Mean Change From Baseline in PANSS Positive Subscale Score

  From Baseline up to 52 Weeks

• Mean Change From Baseline in PANSS Negative Subscale Score

  From Baseline up to 52 Weeks

• Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score

  From Baseline up to 52 Weeks

• Mean Change From Baseline in Personal and Social Performance Scale Total Score

  From Baseline up to 52 Weeks

Study Arms (1)

OPC-34712

EXPERIMENTAL

Drug: OPC-34712

Interventions

OPC-34712 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

OPC-34712

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
• Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
• Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.

You may not qualify if:

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
• 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
• Subjects presenting with a first episode of schizophrenia

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (148)

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Birmingham, Alabama, 35226, United States

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Little Rock, Arkansas, 72201, United States

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Little Rock, Arkansas, 72205, United States

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Springdale, Arkansas, 72764, United States

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Anaheim, California, 92805, United States

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Cerritos, California, 90703, United States

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Escondido, California, 92025, United States

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Garden Grove, California, 92845, United States

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Glendale, California, 91206, United States

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Long Beach, California, 90813, United States

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National City, California, 91950, United States

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Oakland, California, 94612, United States

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Oceanside, California, 92056, United States

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Pico Rivera, California, 90660, United States

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San Diego, California, 92102, United States

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San Diego, California, 92103, United States

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San Diego, California, 92123, United States

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Torrance, California, 90502, United States

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Washington D.C., District of Columbia, 20016, United States

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Bradenton, Florida, 34208, United States

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Leesburg, Florida, 34748, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33143, United States

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Miami Springs, Florida, 33166, United States

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North Miami, Florida, 33162, United States

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Tampa, Florida, 33613, United States

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Chicago, Illinois, 60611, United States

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Hoffman Estates, Illinois, 60169, United States

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Joliet, Illinois, 60435, United States

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Oak Brook, Illinois, 60523, United States

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Overland Park, Kansas, 66212, United States

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Lake Charles, Louisiana, 70629, United States

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Shreveport, Louisiana, 71104, United States

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Flowood, Mississippi, 39232, United States

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Saint Charles, Missouri, 63301, United States

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St Louis, Missouri, 63109, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89102, United States

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Buffalo, New York, 14215, United States

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Cedarhurst, New York, 11516, United States

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Jamaica, New York, 11432, United States

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Rochester, New York, 14618, United States

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Staten Island, New York, 10305, United States

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Staten Island, New York, 10312, United States

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Dayton, Ohio, 45417, United States

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Allentown, Pennsylvania, 18104, United States

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Norristown, Pennsylvania, 19403, United States

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Charleston, South Carolina, 29407, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78754, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75243, United States

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Houston, Texas, 77007, United States

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Richmond, Virginia, 23230, United States

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Kirkland, Washington, 98033, United States

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Burlington, Ontario, L7R 4E2, Canada

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Chatham, Ontario, N7M 5L9, Canada

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Barranquilla, 00000, Colombia

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Bello, 00000, Colombia

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Bogotá, 00000, Colombia

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Pereira, 00000, Colombia

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Rijeka, 51000, Croatia

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Zagreb, 10090, Croatia

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Fujisawa-shi, Kanagawa, 251-8530, Japan

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Kumamoto, Kumamoto, 861-8002, Japan

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Kunigami-gun, Okinawa, 904-1201, Japan

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Sakai-shi, Osaka, 590-0018, Japan

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Daugavpils, LV-5417, Latvia

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Jelgava, LV-3008, Latvia

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Liepāja, LV-3401, Latvia

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Riga, LV-1005, Latvia

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Strenči, LV-4730, Latvia

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Kota Bharu, Kelantan, 15586, Malaysia

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Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

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Kajang, Selangor, 43000, Malaysia

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Ipoh, 31250, Malaysia

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Jalan Greentown, 30450, Malaysia

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Sabak Bernam, 88815, Malaysia

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Col. Florida, Mexico City, 01030, Mexico

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Monterrey, Nuevo León, 64060, Mexico

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San Luis Potosí City, San Luis Potos, 78218, Mexico

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Cebu City, 6000, Philippines

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Davao City, 8000, Philippines

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Manila, 1000, Philippines

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Choroszcz, 16-070, Poland

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Gdansk, 80-282, Poland

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Gdansk, 80-952, Poland

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Lodz, 91-229, Poland

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San Juan, 00918, Puerto Rico

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San Juan, 00927, Puerto Rico

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Arad, 310022, Romania

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Brasov, 500123, Romania

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Bucharest, 010825, Romania

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Bucharest, 030442, Romania

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Bucharest, 041914, Romania

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Cluj-Napoca, 400012, Romania

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Craiova, 200473, Romania

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Focşani, 620165, Romania

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Iași, 700282, Romania

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Piteşti, 110069, Romania

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Târgovişte, 130086, Romania

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Arkhangelsk, 163530, Russia

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Moscow, 117152, Russia

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Moscow, 119435, Russia

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Moscow Region, 142601, Russia

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Nizhny Novgorod, 603155, Russia

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Petrozavodsk, 185000, Russia

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Saint Petersburg, 190005, Russia

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 192019, Russia

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Saint Petersburg, 194214, Russia

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Saint Petersburg, 197341, Russia

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Samara, 443016, Russia

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Saratov, 410060, Russia

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Tomsk, 634014, Russia

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Village Nikolskoe, 188357, Russia

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Belgrade, 11000, Serbia

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Kragujevac, 34000, Serbia

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Novi Kneževac, 23330, Serbia

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Novi Sad, 21000, Serbia

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Bratislava, 82606, Slovakia

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Michalovce, 07101, Slovakia

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Rimavská Sobota, 97912, Slovakia

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Rožňava, 04801, Slovakia

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Incheon, 400-711, South Korea

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Incheon, 405-760, South Korea

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Seoul, 136-705, South Korea

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Seoul, 137-710, South Korea

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Seoul, 143-711, South Korea

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Kashsiung, 802, Taiwan

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New Taipei City, 249, Taiwan

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Taipei, 110, Taiwan

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Taoyuan, 333, Taiwan

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Diyarbakır, 21280, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Chernihiv, 14000, Ukraine

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Dnipropetrovsk, 49027, Ukraine

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Dnipropetrovsk, 49115, Ukraine

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Hlevakha, 08631, Ukraine

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Kharkiv, 61068, Ukraine

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Kherson, Vil. Stepanivka, 73488, Ukraine

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Kyiv, 02660, Ukraine

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Kyiv, 04080, Ukraine

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Lviv, 79021, Ukraine

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Odesa, 65014, Ukraine

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Simferopol, 95006, Ukraine

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Vinnytsia, 21005, Ukraine

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Related Publications (5)

• 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.

  PMID: 35235720 DERIVED

• 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.

  PMID: 34901863 DERIVED

• 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.

  PMID: 29985680 DERIVED

• 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.

  PMID: 29415258 DERIVED

• 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.

  PMID: 27188270 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Aleksandar Skuban, M.D.

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 20, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 10, 2017
• Results First Posted: March 27, 2017

Record last verified: 2017-04

Locations

CO (4); RU (15); TU (2); RO (11); PH (3); TW (4); MY (6); JP (4); PL (4); ME (3); PR (2); CA (2); US (56); UA (12); CR (2); KR (5); SE (4); SL (4); LA (5)