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Last Updated: May 21, 2022

CLINICAL TRIALS PROFILE FOR REXULTI


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All Clinical Trials for Rexulti

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02934932 ↗ A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD Terminated Otsuka America Pharmaceutical Phase 2 2017-04-25 Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron target engagement in a group of subjects with PTSD. All subjects will be evaluated by physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing, and urinalysis. Results of these studies must demonstrate a lack of clinically significant abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil diameter during pupillometric evaluation after two weeks on each treatment will serve as the primary outcome measure. This will be compared in the treatment groups using mixed effects repeated measures models to evaluate if there is a significant difference in pupil size among the treatments studied. As a secondary analysis this approach will be used to evaluate whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will compute correlations between pupil size and CAPS-5 scores.
NCT02934932 ↗ A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD Terminated Duke University Phase 2 2017-04-25 Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron target engagement in a group of subjects with PTSD. All subjects will be evaluated by physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing, and urinalysis. Results of these studies must demonstrate a lack of clinically significant abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil diameter during pupillometric evaluation after two weeks on each treatment will serve as the primary outcome measure. This will be compared in the treatment groups using mixed effects repeated measures models to evaluate if there is a significant difference in pupil size among the treatments studied. As a secondary analysis this approach will be used to evaluate whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will compute correlations between pupil size and CAPS-5 scores.
NCT03149991 ↗ A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD) Completed Massachusetts General Hospital Phase 4 2017-09-14 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rexulti

Condition Name

Condition Name for Rexulti
Intervention Trials
Major Depressive Disorder 3
Post Traumatic Stress Disorder 3
Borderline Personality Disorder 2
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Condition MeSH

Condition MeSH for Rexulti
Intervention Trials
Depressive Disorder 5
Depression 5
Stress Disorders, Traumatic 3
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Clinical Trial Locations for Rexulti

Trials by Country

Trials by Country for Rexulti
Location Trials
United States 23
Canada 6
Japan 1
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Trials by US State

Trials by US State for Rexulti
Location Trials
New York 5
Texas 3
Illinois 3
California 3
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 3
Phase 3 3
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Rexulti
Clinical Trial Phase Trials
Completed 5
Recruiting 4
Not yet recruiting 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 3
Unity Health Toronto 2
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Sponsor Type

Sponsor Type for Rexulti
Sponsor Trials
Other 31
Industry 8
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