Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
NCT ID: NCT04819776
Last Updated: 2024-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
417 participants
INTERVENTIONAL
2021-03-22
2023-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iloperidone
Iloperidone
Oral iloperidone
Placebo
Iloperidone Placebo
Oral placebo
Interventions
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Iloperidone
Oral iloperidone
Iloperidone Placebo
Oral placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
* Voluntary hospitalization for current manic episode
Exclusion Criteria
* Patients who are experiencing a first manic episode or meeting criteria for rapid cycling
18 Years
65 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Little Rock, Arkansas, United States
Vanda Investigational Site
Rogers, Arkansas, United States
Vanda Investigational Site
Cerritos, California, United States
Vanda Investigational Site
Culver City, California, United States
Vanda Investigational Site
Long Beach, California, United States
Vanda Investigational Site
Orange, California, United States
Vanda Investigational Site
Torrance, California, United States
Vanda Investigational Site
Miami Lakes, Florida, United States
Vanda Investigational Site
Oakland Park, Florida, United States
Vanda Investigational Site
Atlanta, Georgia, United States
Vanda Investigational Site
Decatur, Georgia, United States
Vanda Investigational Site
Gaithersburg, Maryland, United States
Vanda Investigational Site
Flowood, Mississippi, United States
Vanda Investigational Site
Las Vegas, Nevada, United States
Vanda Investigational Site
Marlton, New Jersey, United States
Vanda Investigational Site
Dayton, Ohio, United States
Vanda Investigational Site
North Canton, Ohio, United States
Vanda Investigational Site
Austin, Texas, United States
Vanda Investigational Site
DeSoto, Texas, United States
Vanda Investigational Site
Richardson, Texas, United States
Vanda Investigational Site
Novi Iskar, Sofia-Grad, Bulgaria
Vanda Investigational Site
Tserova Koria, Veliko Tarnovo, Bulgaria
Vanda Investigational Site
Kardzhali, , Bulgaria
Vanda Investigational Site
Lovech, , Bulgaria
Vanda Investigational Site
Veliko Tarnovo, , Bulgaria
Vanda Investigational Site
Vratsa, , Bulgaria
Vanda Investigational Site
Tuszyn, , Poland
Countries
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References
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Torres R, Czeisler EL, Chadwick SR, Stahl SM, Smieszek SP, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024 Jan 15;85(1):23m14966. doi: 10.4088/JCP.23m14966.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VP-VYV-683-3201
Identifier Type: -
Identifier Source: org_study_id
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