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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01397786
First received: July 11, 2011
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: OPC-34712
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Outcome Measure - safety and tolerability of OPC-34712 to be assessed by examining the frequency and severity of adverse events. [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale Positive Subscale, Negative Subscale and Total Scores. [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

    Change in Clinical Global Impression -Severity of Illness scale score

    • Change in Personal and Social Performance scale Total Score
    • Mean Clinical Global Impression - Improvement scale score
    • Improved Response rate
    • Discontinuation rate for lack of efficacy

  • Complete Physical Exam, including Clinical Laboratory Tests [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-34712 Drug: 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


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. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397786

  Show 99 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01397786     History of Changes
Other Study ID Numbers: 331-10-237
Study First Received: July 11, 2011
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare
Korea: 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 April 22, 2014