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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01668797
Other study ID # 331-10-232
Secondary ID 2011-005766-38
Status Completed
Phase Phase 3
First received August 16, 2012
Last updated July 20, 2015
Start date October 2012
Est. completion date February 2015

Study information

Verified date July 2015
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment 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 524
Est. completion date February 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)

- Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).

- Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).

- Subjects who showed previous response to antipsychotic treatment in the past year.

- Subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.

- Subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization

- Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Exclusion Criteria:

- Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product

- Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator

- Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis ? criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

- Subjects experiencing acute depressive symptoms within the past 30 days

- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history

- Subjects with a significant risk of violent behavior; who represent a risk of committing suicide

- Subjects with clinically significant tardive dyskinesia

- Subjects currently treated with insulin for diabetes.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Brexpiprazole
Brexpiprazole tablets 1 to 4 mg /day
Placebo
Placebo comparator for 52 weeks

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc. Quintiles, Inc.

Countries where clinical trial is conducted

United States,  Colombia,  Malaysia,  Puerto Rico,  Romania,  Serbia,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Outcome Measure: The primary efficacy endpoint of this trial is the time from randomization to exacerbation of psychotic symptoms/impending relapse in Phase C. From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks No
Secondary Outcome Measure: the percentage of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks No
See also
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Recruiting NCT05325645 - Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia Phase 3
Completed NCT00350467 - A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of Schizophrenia Phase 3
Completed NCT03160521 - Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia Phase 3
Completed NCT01393613 - Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia Phase 3
Completed NCT01396421 - Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia Phase 3
Completed NCT00140166 - Treatment of Acute Schizophrenia With Vitamin Therapy Phase 4
Completed NCT01490086 - RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder Phase 2
Unknown status NCT00838032 - Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia Phase 4