This site is intended for healthcare professionals
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • A Trial to Evaluate the Safety and Tolerability of...
Clinical trial

A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder

Read time: 3 mins
Last updated:1st Sep 2017
Identifier: NCT03287869

This study will evaluate the safety and tolerability of brexpiprazole (OPC-34712) in the treatment of subjects with bipolar I disorder. All subjects will receive a starting dose of brexpiprazole which will be titrated up in subsequent visits.


Study Type: Interventional
Intervention Model: Single Group Assignment
Intervention Model Description: Group composed of eligible rollover subjects who completed one of the double-blind, phase 3 efficacy trials (331-201-00080 or 331-201-00081). In the event the sponsor determines that the enrollment rate of rollover subjects will not be sufficient to meet the target completion, de novo subjects may be enrolled at select sites. The enrollment of de novo subjects at any site will not be permitted until initiation and notification by the sponsor.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder
Estimated Enrollment: 384
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Brexpiprazole

Category Value
Date last updated at source 2017-09-19
Study type(s) Interventional
Expected enrolment 348
Study start date 2017-09-01
Estimated primary completion date 2019-07-01

View full details