Clinical trial NCT02013622: Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
Official title: Protocol 331-13-006: An Exploratory, Multicenter, Open-label, Monotherapy, Flexible-dose Brexpiprazole (OPC 34712) Trial in Adults With Early Episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
Mental Disorders
Psychotic Disorders
social avoidance
emotional withdrawal
passive/apathetic
social withdrawal
antipsychotic
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-12-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as episodes occurring ≤ 5 years after the onset of the first episode.


Eligibility criteria: Inclusion Criteria: Have 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 both the Mini International Neuropsychiatric Interview (M.I.N.I.) for Schizophrenia and Psychotic Disorders Studies and an adequate clinical psychiatric evaluation.

* Had the start of their first schizophrenia episode ≤ 5 years before the time of consent.
* Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).
* Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening and baseline.
* Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking.
* Have a diagnosis of schizophrenia made at least 6 months prior to screening as confirmed by subject, caregiver, or documented history.

Exclusion Criteria: Subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator.

* Subjects who have been hospitalized for psychotic symptoms within the last 6 months.
* Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only.
* Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders.
* Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
* Subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of\>= 3 on Item 8 of the AIMS at screening or baseline.
* Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.
* Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine.

Primary outcomes:
measure: Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score
timeFrame: Baseline and Week 16
measure: Mean Clinical Global Impression-Improvement (CGI-I) Score
timeFrame: Week 1 to Week 16
measure: CGI-I Response Rate
timeFrame: Weeks 4, 8, 12, and 16
measure: Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Food Delay Discounting Task
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Money Delay Discounting Task
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Cerritos
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Oakland
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Fort lauderdale
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Hoffman Estates
country: United States
state: Illinois
city: Lake Charles
country: United States
state: Louisiana
city: Rochester
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
name: Junichi Hashimoto, PhD
role: STUDY_DIRECTOR
References: