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Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02194933
First Posted: July 21, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
The purpose of this study is to evaluate the effect of brexpiprazole, via functional magnetic resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC) activated by impulsive behavior.

Condition Intervention Phase
Schizophrenia With Impulsivity Drug: Brexpiprazole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protocol 331-13-009: An Exploratory, Multicenter, Randomized, Double-Blind, fMRI Study of Fixed-dose Brexpiprazole (OPC-34712) (2 and 4 mg/Day Tablets) in Adults With Schizophrenia With Impulsivity

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline brain activation in the VLPFC based on change from baseline to Week 6 in fMRI blood oxygen-level dependent (BOLD) activation score in the right VLPFC during performance of the Go/No-go Task [ Time Frame: Week 6 ]
  • Change from baseline brain activation in the VLPFC based on change from baseline to Week 6 in fMRI BOLD activation score in the right VLPFC during performance of the SSRT Task [ Time Frame: Week 6 ]

Secondary Outcome Measures:
  • Change from baseline to Week 3 in fMRI BOLD activation score in the right VLPFC, scanned by fMRI during performance of tasks associated with impulsivity (SSRT Task, Go/No-go Task) [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11) [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in BIS-11 [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in Go/No-go Task behavior [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in Go/No-go Task behavior [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in Monetary Choice Questionnaire (MCQ) score [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in MCQ score [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in Stop Signal Reaction Time Task (SSRT) Task behavior [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in SSRT Task behavior [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in Continuous Performance Task (CPT) behavior [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in CPT behavior [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in PANSS Total Score [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in PANSS Positive Subscale Score [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in PANSS Positive Subscale Score [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in PANSS Negative Subscale Score [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in PANSS Negative Subscale Score [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) score [ Time Frame: Week 6 ]
  • Change from baseline to Week 3 in CGI-S score [ Time Frame: Week 3 ]
  • Clinical Global Impression - Improvement Scale (CGI-I) score at Week 6 [ Time Frame: Week 6 ]
  • CGI-I score at Week 3 [ Time Frame: Week 3 ]
  • Change from baseline to Week 6 in Personal and Social Performance Scale (PSP) [ Time Frame: Week 6 ]

Enrollment: 38
Study Start Date: February 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brexpiprazole 2 mg
Brexpiprazole 2 mg/day, once daily dose, tablet, orally
Drug: Brexpiprazole
Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks
Other Name: OPC-34712
Experimental: Brexpiprazole 4 mg
Brexpiprazole 4 mg/day, once daily dose, tablet, orally
Drug: Brexpiprazole
Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks
Other Name: OPC-34712

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are 18 to 65 years of age, inclusive, at the time of informed consent (outpatients only), with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and confirmed by both the M.I.N.I. for Schizophrenia and Psychotic Disorders Studies, and an adequate clinical psychiatric evaluation.
  • Have a CGI-S score of ≤ 4 (moderately ill) at screening and baseline.
  • Have a score of ≤ 4 (moderate) on PANSS item G8 (uncooperativeness) at screening and baseline.
  • Have a BIS-11 score of ≥ 50 at screening and baseline.
  • Willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.
  • Are stable on their current oral antipsychotic medication (no changes within the last month) and are able to meet protocol-required washouts of their current antipsychotic medication.
  • Have received previous outpatient antipsychotic treatment at an adequate dose (at least minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the investigator's opinion.
  • Subjects with eyesight that is sufficient to be able to see visual displays, or correctable with magnet-compatible glasses or contact lenses.
  • Subjects fluent in English

Exclusion Criteria:

  • Are presenting with schizophreniform or with a first episode of schizophrenia based on the clinical judgment of the investigator.
  • Have been hospitalized for psychotic symptoms within the previous 6 months.
  • Have a current DSM-IV-TR Axis I primary diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder, bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder (OCD) or panic disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders, or mental retardation.
  • Have worsening of ≥ 20% in total PANSS score between the screening and baseline assessments.
  • Experiencing a deterioration in clinical status or an acute exacerbation of schizophrenia in the opinion of the Investigator.
  • Experiencing acute onset of clinically significant depressive symptoms within the past 30 days, according to the investigator's opinion.
  • Answer "Yes" on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR who, in the opinion of the investigator, present a serious risk of suicide.
  • Have a history of stroke.
  • Contraindications to magnetic resonance imaging (MRI) such as metal prostheses, pacemakers, claustrophobia, movement disorders, waist circumference more than 56 inches or head circumference more than 29 inches, color blindness, significant tremors, or history of head injury or prolonged unconsciousness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194933


Locations
United States, California
University of California at Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02194933     History of Changes
Other Study ID Numbers: 331-13-009
First Submitted: July 16, 2014
First Posted: July 21, 2014
Last Update Posted: October 12, 2017
Last Verified: August 2016

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Schizophrenia
Mental Disorders, Antipsychotic,
Psychotic disorder, Impulsivity

Additional relevant MeSH terms:
Schizophrenia
Impulsive Behavior
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents