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



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:11/10/2018
Start Date:February 2015
End Date:April 2016

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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

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.


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
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
714-456-7890
Phone: 949-824-8040
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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