Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lurasidone 20 mg
Lurasidone 20 mg
Lurasidone 20 mg once daily orally in the evening
Lurasidone 60 mg
Lurasidone 60 mg
Lurasidone 60 mg once daily orally in the evening
Placebo
Placebo
Placebo once daily orally in the evening
Interventions
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Lurasidone 20 mg
Lurasidone 20 mg once daily orally in the evening
Lurasidone 60 mg
Lurasidone 60 mg once daily orally in the evening
Placebo
Placebo once daily orally in the evening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Subject is 18 to 75 years of age, inclusive. Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured Clinical Interview for DSM-IV Disorders - Clinical Trial version \[SCID-CT\]).
Subject is currently experiencing a major depressive episode (diagnosed by DSM-IV-TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050305):
* Elevated, expansive mood
* Inflated self-esteem or grandiosity
* More talkative than usual or pressure to keep talking
* Flight of ideas or subjective experience that thoughts are racing
* Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
* Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
* Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) Subject has a rater-administered Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) MADRS total score ≥ 26 at baseline.
Exclusion Criteria
Subject has attempted suicide within the past 3 months. Subject has a lifetime history of any bipolar I manic or mixed manic episode. Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
18 Years
75 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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Birmingham Research Group
Birmingham, Alabama, United States
Sun Valley Behavioral Medical
Imperial, California, United States
Synergy Clinical Research Center
National City, California, United States
Excell Research
Oceanside, California, United States
Pacific Clinical Research Medical Group
Orange, California, United States
SMRI
Sherman Oaks, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Florida Research Center
Maitland, Florida, United States
University of Miami, Miller School
Miami, Florida, United States
Miami Research
Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Comprehensive NeuroScience Inc.
Atlanta, Georgia, United States
Hawaii Clinical Research Center
Honolulu, Hawaii, United States
Psychiatric Medicine Associates
Skokie, Illinois, United States
Goldpoint Clinical Research
Indianapolis, Indiana, United States
CRI Worldwide
Willingboro, New Jersey, United States
Medical & Behavioral Health Research
New York, New York, United States
Montefiore Medical Center; Anxiety & Depression Clinic; Dept. of Psychiatry
The Bronx, New York, United States
New Hope Clinical Research
Hickory, North Carolina, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Harry Croft and Associates
San Antonio, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Department of Psychiatry, University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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References
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Goldberg JF, Siu C, Mao Y, Tsai J, Pikalov A, Calabrese JR, Loebel A. Major depressive disorder with mixed features and treatment response to lurasidone: A symptom network model. J Affect Disord. 2020 Dec 1;277:1045-1054. doi: 10.1016/j.jad.2020.08.048. Epub 2020 Aug 26.
Suppes T, Silva R, Cucchiaro J, Mao Y, Targum S, Streicher C, Pikalov A, Loebel A. Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features: A Randomized, Double-Blind, Placebo-Controlled Study. Am J Psychiatry. 2016 Apr 1;173(4):400-7. doi: 10.1176/appi.ajp.2015.15060770. Epub 2015 Nov 10.
Other Identifiers
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D1050305
Identifier Type: -
Identifier Source: org_study_id