Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia

NCT00905307 | Completed Phase 2 Results DMC

• 1 other identifier: 331-07-203
• Study Type: interventional
• Target: 459
• Locations: 12 countries
• Sites: 73

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Relapsed

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)

  The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.

  Baseline to Week 6

Secondary Outcomes (7)

• Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)

  Baseline to Week 6

• Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)

  Baseline to Week 6

• Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)

  Baseline to Week 6

• Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)

  Baseline to Week 6

• Mean Clinical Global Impression - Improvement (CGI-I) at Week 6

  Week 6

Study Arms (6)

1

EXPERIMENTAL

OPC-34712 0.25 mg arm

Drug: OPC-34712

2

EXPERIMENTAL

OPC-34712 low-dose arm

Drug: OPC-34712

3

EXPERIMENTAL

OPC-34712 mid-dose arm

Drug: OPC-34712

4

EXPERIMENTAL

OPC-34712 high-dose arm

Drug: OPC-34712

5

PLACEBO COMPARATOR

Drug: Placebo

6

ACTIVE COMPARATOR

Aripiprazole arm

Drug: Aripiprazole

Interventions

OPC-34712 DRUG

oral, once daily

1; 2; 3; 4

Placebo DRUG

Placebo

5

Aripiprazole DRUG

oral, once daily

6

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
• Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
• Subjects experiencing an acute exacerbation of psychotic symptoms

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 (73)

Study Site

Little Rock, Arkansas, 72211, United States

Location

Study Site

Escondido, California, 92025, United States

Location

Study Site

Garden Grove, California, 92645, United States

Location

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Long Beach, California, 90813, United States

Location

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Oceanside, California, 92056, United States

Location

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Pasadena, California, 91107, United States

Location

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San Diego, California, 92102, United States

Location

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San Diego, California, 92123, United States

Location

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Santa Ana, California, 92701, United States

Location

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

Location

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Bradenton, Florida, 34208, United States

Location

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Maitland, Florida, 32751, United States

Location

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St Louis, Missouri, 63118, United States

Location

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Cedarhurst, New York, 11516, United States

Location

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Philadelphia, Pennsylvania, 19139, United States

Location

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Austin, Texas, 78756, United States

Location

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Burgas, 8000, Bulgaria

Location

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Kazanlak, 6100, Bulgaria

Location

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Pazardzhik, 4400, Bulgaria

Location

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Plovdiv, 4002, Bulgaria

Location

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Radnevo, 6260, Bulgaria

Location

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Rousse, 7003, Bulgaria

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Rijeka, 51000, Croatia

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Split, 21000, Croatia

Location

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Zagreb, 10090, Croatia

Location

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Vijaywada, Andh Prad, 520002, India

Location

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Visakhapatnam, Andh Prad, 530017, India

Location

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Ahmedabad, Gujarat, 380015, India

Location

Study Site

Bangalore, Karna, 560010, India

Location

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Mangalore, Karna, 575001, India

Location

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Mangalore, Karna, 575018, India

Location

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Pune, Mahara, 411004, India

Location

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Chennai, Tamil Nadu, 600003, India

Location

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Varanasi, Uttar Prad, 221005, India

Location

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Cebu City, Philippines

Location

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Mandaluyong, Philippines

Location

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Arad, 310022, Romania

Location

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Bucharest, 010825, Romania

Location

Study Site (1)

Bucharest, 041914, Romania

Location

Study Site (2)

Bucharest, 041914, Romania

Location

Study Site (3)

Bucharest, 041914, Romania

Location

Study Site

Cluj-Napoca, 400012, Romania

Location

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Oradea, 410154, Romania

Location

Study Site

Moscow, 113152, Russia

Location

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Moscow, 115522, Russia

Location

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Moscow Region, 141371, Russia

Location

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Saint Petersburg, 190121, Russia

Location

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Saint Petersburg, 193167, Russia

Location

Study Site

Saint Petersburg, 197341, Russia

Location

Study Site (1)

Belgrade, 11000, Serbia

Location

Study Site (2)

Belgrade, 11000, Serbia

Location

Study Site

Kragujevac, 34000, Serbia

Location

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Novi Sad, 21000, Serbia

Location

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Bojnice, 92701, Slovakia

Location

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Bratislava, 82606, Slovakia

Location

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Liptovský Mikuláš, 03123, Slovakia

Location

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Rimavská Sobota, 97912, Slovakia

Location

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Žilina, 01207, Slovakia

Location

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Busan, 613-735, South Korea

Location

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Chuncheon, 200-704, South Korea

Location

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Incheon, 400-711, South Korea

Location

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Incheon, 405-760, South Korea

Location

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Seoul, 143-711, South Korea

Location

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Hualien Town, 970, Taiwan

Location

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Taipei, 249, Taiwan

Location

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Chernihiv, 14005, Ukraine

Location

Study Site

Dnipropetrovsk, 49005, Ukraine

Location

Study Site

Kherson,Vil. Stepanivka, 73488, Ukraine

Location

Study Site

Kyiv, 02660, Ukraine

Location

Study Site

Kyiv, 04080, Ukraine

Location

Study Site

Kyiv, 04655, Ukraine

Location

Study Site

Simferopol, 95006, Ukraine

Location

Study Site

Vinnitsia, 21018, Ukraine

Location

Related Publications (2)

• 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

• 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.

  PMID: 26250067 DERIVED

MeSH Terms

Conditions

Schizophrenia; Recurrence

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

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

800-562-3924

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 20, 2015
• Results First Posted: September 3, 2015

Record last verified: 2015-09

Locations

KR (5); US (16); SE (4); TW (2); RO (7); BU (6); PH (2); UA (8); CR (3); IN (9); RU (6); SL (5)