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Last Updated: August 8, 2020

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CLINICAL TRIALS PROFILE FOR REXULTI

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All Clinical Trials for Rexulti

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03149991 A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD) Not yet recruiting Massachusetts General Hospital Phase 4 2017-06-01 This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable, and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive Disorder with Treatment Resistant Depression.
NCT03418675 Brexpiprazole in Borderline Personality Disorder Not yet recruiting Otsuka America Pharmaceutical Phase 2 2018-07-01 The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.
NCT03418675 Brexpiprazole in Borderline Personality Disorder Not yet recruiting University of Chicago Phase 2 2018-07-01 The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.
NCT03427892 Brexpiprazole for Bipolar Depression Completed Otsuka America Pharmaceutical Phase 4 2017-03-01 The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an assessment of the following in patients with bipolar disorder taking brexpiprazole: manic symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder, development of active suicidal or homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe life-threatening medical condition, involuntary psychiatric hospitalization or incarceration.
NCT03427892 Brexpiprazole for Bipolar Depression Completed University of Texas Southwestern Medical Center Phase 4 2017-03-01 The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an assessment of the following in patients with bipolar disorder taking brexpiprazole: manic symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder, development of active suicidal or homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe life-threatening medical condition, involuntary psychiatric hospitalization or incarceration.
NCT03557931 A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication Recruiting Astellas Pharma Global Development, Inc. Phase 2 2018-07-13 The purpose of this study is to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand will use a Hypothetical Strategy and compare participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study will also evaluate the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluate the pharmacokinetic profile of ASP4345 and its metabolites, if necessary.
NCT03697603 A Study of Brexpiprazole in Patients With Major Depressive Disorder Recruiting Otsuka Pharmaceutical Co., Ltd. Phase 2/Phase 3 2018-07-30 The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rexulti

Condition Name

Condition Name for Rexulti
Intervention Trials
Borderline Personality Disorder 2
Post Traumatic Stress Disorder 2
Major Depressive Disorder 2
Bipolar Depression 1
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Condition MeSH

Condition MeSH for Rexulti
Intervention Trials
Depressive Disorder 4
Depression 4
Disease 3
Borderline Personality Disorder 2
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Clinical Trial Locations for Rexulti

Trials by Country

Trials by Country for Rexulti
Location Trials
United States 17
Canada 3
Japan 1
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Trials by US State

Trials by US State for Rexulti
Location Trials
New York 3
Texas 3
California 2
Illinois 2
Ohio 1
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Clinical Trial Progress for Rexulti

Clinical Trial Phase

Clinical Trial Phase for Rexulti
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Rexulti
Clinical Trial Phase Trials
Not yet recruiting 4
Recruiting 4
Completed 1
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Clinical Trial Sponsors for Rexulti

Sponsor Name

Sponsor Name for Rexulti
Sponsor Trials
Otsuka Pharmaceutical Development & Commercialization, Inc. 3
Otsuka America Pharmaceutical 2
University of Texas Southwestern Medical Center 1
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Sponsor Type

Sponsor Type for Rexulti
Sponsor Trials
Other 16
Industry 7
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