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

NCT02013622 | Completed Phase 3 Results

• 1 other identifier: 331-13-006
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 22

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.

Conditions

Schizophrenia

Keywords

schizophrenia; Mental Disorders; Psychotic Disorders; social avoidance; emotional withdrawal; passive/apathetic; social withdrawal; antipsychotic

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).

  Baseline and Week 16

Secondary Outcomes (16)

• 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

  Baseline and Week 16

• Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score

  Baseline and Week 16

• Mean Clinical Global Impression-Improvement (CGI-I) Score

  Week 1 to Week 16

• CGI-I Response Rate

  Weeks 4, 8, 12, and 16

• Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score

  Baseline and Week 16

Study Arms (1)

Brexpiprazole

EXPERIMENTAL

Up to 4 mg/day, once daily dose, tablets, orally

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

Treatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally

Brexpiprazole

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (22)

Unknown Facility

Cerritos, California, 90703, United States

Location

Unknown Facility

Chula Vista, California, 92105, United States

Location

Unknown Facility

Costa Mesa, California, 92626, United States

Location

Unknown Facility

Long Beach, California, 90806, United States

Location

Unknown Facility

Oakland, California, 94612, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Pico Rivera, California, 90660, United States

Location

Unknown Facility

Riverside, California, 92506, United States

Location

Unknown Facility

San Diego, California, 92102, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

Santa Ana, California, 92705, United States

Location

Unknown Facility

Torrance, California, 90502, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33334, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Hoffman Estates, Illinois, 60169, United States

Location

Unknown Facility

Lake Charles, Louisiana, 70629, United States

Location

Unknown Facility

Rochester, New York, 14618, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19139, United States

Location

Unknown Facility

Memphis, Tennessee, 38119, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

Unknown Facility

Dallas, Texas, 75243, United States

Location

Unknown Facility

Houston, Texas, 77007, United States

Location

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders; Lethargy

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Junichi Hashimoto, PhD

  Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 17, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 29, 2016
• Results First Posted: March 29, 2016

Record last verified: 2016-02

Locations

US (22)