A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
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|ClinicalTrials.gov Identifier: NCT04100096|
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : May 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Borderline Personality Disorder||Drug: Brexpiprazole Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder|
|Actual Study Start Date :||October 17, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
2-3 mg/day tablet
Other Name: Rexulti®
Placebo Comparator: Placebo
- Change from baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) total score [ Time Frame: Up to 12 weeks ]A clinician-administered scale with a total score range of 0 to 36. A higher score represents a higher severity of disease symptoms.
- Change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: Up to 12 weeks ]An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome.
- Change from baseline in the Patient's Global Impression of Severity (PGI-S) for each trial visit during the double-blind treatment period [ Time Frame: Up to 12 weeks ]A 7-point single-item self-report scale for the patient to rate the severity of symptoms of BPD. A higher score denotes more severe symptoms.
- Patient's Global Impression of Change (PGI-C) Scale Score [ Time Frame: Up to 12 weeks ]A 7-point single-item self-report scale depicting a subject's rating of overall change in their condition since starting trial medication. With a higher score denoting a worse outcome.
- Clinical Global Impression - Improvement (CGI-I) Scale Score [ Time Frame: Up to 12 weeks ]An observer-rated scale with a total score of 0 to 7. A higher score represents a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100096
|Contact: Otsuka Call Center||844-687-8522||OtsukaRMReconciliation@rmpdc.org|
|United States, New York|
|For additional information regarding sites, contact 844-687-8522||Recruiting|
|New York, New York, United States, 10012|