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

Schizophrenia Clinical Trial

Official title:

Protocol 331-13-006: An Exploratory, Multicenter, Open-label, Monotherapy, Flexible-dose Brexpiprazole (OPC 34712) Trial in Adults With Early Episode Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013622
• Other study ID #: 331-13-006
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2013
• Last updated: January 13, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS Total Score change from baseline to Week 16		Week 16	No
Secondary	Change from baseline to Week 16 scores in the following negative scale items: active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking		Week 16	No
Secondary	CGI-S score change from baseline to Week 16		Week 16	No
Secondary	CGI-I score at Week 16		Week 16	No
Secondary	Response rates (defined as CGI-I score of 1 [very much improved] or 2 [much improved]) at Weeks 4, 8, 12, and 16		Weeks 4, 8, 12, and 16	No
Secondary	PSP Total Score change from baseline to Week 16		Week 16	No
Secondary	SLOF Total Score change from baseline to Week 16		Week 16	No
Secondary	PSQI Total Score change from baseline to Week 16		Week 16	No
Secondary	TSQM Total Score change from baseline to Week 16		Week 16	No
Secondary	Go/No-Go task change from baseline to Week 16		Week 16	No
Secondary	Delay Discounting task - MCQ scores change from baseline to Week 16		Week 16	No
Secondary	Delay Discounting task - EDT scores change from baseline to Week 16		Week 16	No
Secondary	BIS-11 change from baseline to Week 16		Week 16	No