Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment
NCT ID: NCT02013609
Last Updated: 2016-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2013-11-30
2014-10-31
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 3mg/day, once daily dose, tablets, orally
Brexpiprazole
Treatment 12 weeks) - Up to 3 mg/day, once daily dose, tablets, orally
Interventions
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Brexpiprazole
Treatment 12 weeks) - Up to 3 mg/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 35 years old at the time of consent (inclusive, and outpatients only).
Are (and will be) working 20 hours or more per week or a student taking 6 credit hours or more during the trial period, however minor deviations from the "part-time" concept may be acceptable on a case-by-case basis based on approval of the medical monitor.
Have a Hamilton Depression Rating Scale (HAM-D)- 17-item Total Score ≥ 18 at screening and baseline.
Have a Sheehan Disability Scale (SDS) 3-item mean score ≥ 5 at baseline.
Exclusion Criteria
Subjects with any of the following current Axis II DSM-IV-TR diagnoses: borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental retardation.
18 Years
35 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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Cerritos, California, United States
Costa Mesa, California, United States
Garden Grove, California, United States
Glendale, California, United States
Orange, California, United States
Riverside, California, United States
San Diego, California, United States
Norwich, Connecticut, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Melbourne, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Prairie Village, Kansas, United States
Weymouth, Massachusetts, United States
Las Vegas, Nevada, United States
Brooklyn, New York, United States
Jamaica, New York, United States
Staten Island, New York, United States
Portland, Oregon, United States
Austin, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, 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.
Other Identifiers
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331-13-003
Identifier Type: -
Identifier Source: org_study_id
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