Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia (BEACON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01393613
First received: July 11, 2011
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.


Condition Intervention Phase
Acute Schizophrenia
Drug: OPC-34712
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Fixed-dose OPC-34712 in the Treatment of Adults With Acute Schizophrenia

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • The change in Positive and Negative Syndrome Scale Total Score. [ Time Frame: First treatment visit to Week 6/Early Termination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Clinical Global Impression - Severity of Illness scale score. [ Time Frame: first treatment visit to Week 6/Early Termination ] [ Designated as safety issue: No ]

Enrollment: 674
Study Start Date: July 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 3 OPC 34712
Higher dose, tablet, once daily, for six weeks
Drug: OPC-34712
Higher dose tablet, once daily, for six weeks,
Experimental: Dose 2 OPC 34712
Middle dose, tablet, once daily, for six weeks
Drug: OPC-34712
Middle dose tablet, once daily, for six weeks
Experimental: Dose 1 OPC 34712
Lower dose, tablet, once daily, for six weeks
Drug: OPC-34712
Lower dose tablet, once daily, for six weeks
Placebo Comparator: Placebo
Placebo, once daily, for six weeks
Drug: Placebo
Placebo, once daily, for six weeks

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393613

  Show 60 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Aleksandar Skuban, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01393613     History of Changes
Other Study ID Numbers: 331-10-230
Study First Received: July 11, 2011
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
India: Drugs Controller General of India

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014