Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2021-09-22

Brief Summary

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This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.

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Detailed Description

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Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prior Brexpiprazole 2-3 Milligrams Per Day

Participants who received blinded brexpiprazole 2 to 3 milligrams per day (mg/day) in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

Administered as tablets.

Prior Placebo

Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

Administered as tablets.

Interventions

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Brexpiprazole

Administered as tablets.

Intervention Type DRUG

Other Intervention Names

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Rexulti OPC-34712

Eligibility Criteria

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Inclusion Criteria

* Participants, who completed the last treatment visit of the previous double-blind brexpiprazole BPD trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of BPD.
* Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole BPD trial.

Exclusion Criteria

* Sexually active males or females of childbearing potential (FOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. Male participants must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of investigational medicinal product (IMP).
* Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
* Participants who participated in a clinical trial within 90 days prior to screening/baseline (with the exception of a previous brexpiprazole double-blind BPD trial) or who participated in more than 2 clinical trials within a year prior to screening/baseline.
* Participants who develop a medically significant abnormality.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No