Clinical trial NCT02054702: Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
Official title: Protocol 331-13-008: An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Mental Disorders
Psychotic Disorders
Antipsychotic
Cognitive testing
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2014-02-04
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies
* Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
* Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
* Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80
* Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
* Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)

Exclusion Criteria:

* Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
* Have been hospitalized \> 21 days for the current acute episode at the time of the baseline visit
* Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
* Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.

Primary outcomes:
measure: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change From Baseline in Cognitive Test Battery Composite Score
timeFrame: Baseline to Week 6
measure: Change From Baseline in Cognitive Test Battery of Early Phase Battery Score
timeFrame: Baseline to Week 6
measure: Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)
timeFrame: Baseline to Week 6
measure: Change From Baseline in Cognitive Test Battery Scores of Detection Task
timeFrame: Baseline to Week 6
measure: Change From Baseline in Cognitive Test Battery Scores of Identification Task
timeFrame: Baseline to Week 6
measure: Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task
timeFrame: Baseline to Week 6
measure: Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
timeFrame: Baseline to Week 6
measure: Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6
timeFrame: Baseline to Week 6
measure: Response Rate by Study Week
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
name: Junichi Hashimoto, PhD
role: STUDY_DIRECTOR
References: