Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms
NCT ID: NCT02013531
Last Updated: 2016-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2013-11-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brexpiprazole
Up to 3 mg/day, once daily dose, tablets, orally
Brexpiprazole
Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally
Interventions
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Brexpiprazole
Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally
Eligibility Criteria
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Inclusion Criteria
* Have a treatment history of an inadequate ADT response to at least 1 ADT (but not \> 3) for the current episode.
* Have received a single, trial-approved, SSRI or SNRI at an adequate dose for
≥ 6 weeks prior to screening.
* Are 18 to 65 years old at the time of consent (inclusive, and outpatients only).
* Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score ≥ 18 at screening and baseline.
* Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening and baseline.
Exclusion Criteria
* delirium
* dementia
* amnestic
* other cognitive disorders
* schizophrenia
* schizoaffective disorder
* other psychotic disorders
* bipolar I disorder,
* bipolar II disorder
* bipolar disorder not otherwise specified (NOS)
* eating disorders
* anorexia nervosa
* bulimia
* obsessive compulsive disorder
* post-traumatic stress disorder
Subjects with any of the following current Axis II DSM-IV-TR diagnoses:
* borderline, antisocial
* paranoid
* schizoid
* schizotypal
* histrionic personality disorders
* mental retardation.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Junichi Hashimoto, PhD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
Locations
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Tuscon, Arizona, United States
Garden Grove, California, United States
Oceanside, California, United States
Temecula, California, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Lafayette, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Haverhill, Massachusetts, United States
Rochester Hills, Michigan, United States
New York, New York, United States
Staten Island, New York, United States
Salem, Oregon, United States
Allentown, Pennsylvania, United States
Arlington, Texas, United States
Austin, Texas, United States
Woodstock, Vermont, United States
Richmond, Virginia, United States
Countries
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References
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Weiss C, Meehan SR, Brown TM, Gupta C, Morup MF, Thase ME, McIntyre RS, Ismail Z. Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews. J Patient Rep Outcomes. 2021 Dec 11;5(1):128. doi: 10.1186/s41687-021-00380-4.
Davis LL, Ota A, Perry P, Tsuneyoshi K, Weiller E, Baker RA. Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: an exploratory study. Brain Behav. 2016 Jul 24;6(10):e00520. doi: 10.1002/brb3.520. eCollection 2016 Oct.
Other Identifiers
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331-13-002
Identifier Type: -
Identifier Source: org_study_id
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