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

Schizophrenia Clinical Trial

— ZENITH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397786
• Other study ID #: 331-10-237
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2011
• Last updated: October 3, 2016
• Start date: September 2011
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationJapan: Ministry of Health, Labor and WelfareKorea: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1044
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  Croatia,  Japan,  Korea, Republic of,  Latvia,  Malaysia,  Mexico,  Philippines,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Slovakia,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Measure - safety and tolerability of OPC-34712 to be assessed by examining the frequency and severity of adverse events.		up to 52 weeks	Yes
Secondary	Change in Positive and Negative Syndrome Scale Positive Subscale, Negative Subscale and Total Scores.	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	up to 52 weeks	No
Secondary	Complete Physical Exam, including Clinical Laboratory Tests		up to 52 weeks	Yes