Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
NCT ID: NCT01421134
Last Updated: 2016-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
211 participants
INTERVENTIONAL
2011-09-30
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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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lurasidone
Lurasidone 20, 40 or 60 mg
Lurasidone
20, 40, 60 mg, flexible dose, once daily PM 6 weeks
Placebo
Placebo
Placebo
Placebo
Interventions
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Lurasidone
20, 40, 60 mg, flexible dose, once daily PM 6 weeks
Placebo
Placebo
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 D1050304):
* 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)
Exclusion Criteria
* Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
* 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 Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States
Synergy Clinical Research Center
Escondido, California, United States
Collaborative Neuroscience Network Inc.
Garden Grove, California, United States
Stanford -VA Palo Alto Health Care System
Palo Alto, California, United States
Clinical Innovations Inc.
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Florida Clinical Research Center, LLC
Sarasota, Florida, United States
Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, United States
St. Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, United States
Social Psychiatric Research Inst. (SPRI) Clinical Trials
Brooklyn, New York, United States
Village Clinical Research Inc.
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, United States
Psychiatry and Behavioral Sciences, Duke
Durham, North Carolina, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
CRI Worldwide - Kirkbride
Philadelphia, Pennsylvania, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Dept. of Psychiatry, UT Southwestern Medical Center
Dallas, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Saint Nicholas Psychiatric Hospital.
Saint Petersburg, , Russia
City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)
Saint Petersburg, , Russia
Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"
Saint Petersburg, , Russia
Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"
Saratov, , Russia
State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,
Saratov, , Russia
Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"
Stavropol, , Russia
Institute of Mental Health
Belgrade, , Serbia
Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"
Belgrade, , Serbia
Health Centre Cacak Department of Psychiatry
Čačak, , Serbia
Clinical Center Nis, Psychiatric Clinic
Gornja Toponica, , Serbia
Clinical Center Kragujevac, Psychiatric Clinic
Kragujevac, , Serbia
Clinic for Mental Health, Clinical Center Nis
Niš, , Serbia
Special Hospital for Psychiatric Diseases "Sveti Vracevi"
Vojvodina, , Serbia
Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
Vršac, , Serbia
General Hospital "Djordje Joanovic" Psychiatric Dept.
Zrenjanin, , Serbia
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, , Ukraine
State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry
Kharkiv, , Ukraine
Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2
Kyiv, , Ukraine
"Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults
Luhansk, , Ukraine
Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20
Lviv, , Ukraine
Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
Odesa, , Ukraine
Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept. of Psychiatry and Narcology, Vinnytsya Regional Psychoneurological Hospital n.a. O.I. Yushchenko, Dept. no. 14, Dept. no 15
Vinnytsia, , Ukraine
MAC Clinical Research Limited
Cannock, , United Kingdom
MAC Clinical Research Limited
Manchester, , United Kingdom
Countries
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References
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Clayton AH, Tsai J, Mao Y, Pikalov A, Loebel A. Effect of Lurasidone on Sexual Function in Major Depressive Disorder Patients With Subthreshold Hypomanic Symptoms (Mixed Features): Results From a Placebo-Controlled Trial. J Clin Psychiatry. 2018 Aug 7;79(5):18m12132. doi: 10.4088/JCP.18m12132.
Targum SD, Pendergrass JC, Lee S, Loebel A. Ratings surveillance and reliability in a study of major depressive disorder with subthreshold hypomania (mixed features). Int J Methods Psychiatr Res. 2018 Dec;27(4):e1729. doi: 10.1002/mpr.1729. Epub 2018 Jun 26.
Targum SD, Suppes T, Pendergrass JC, Lee S, Silva R, Cucchiaro J, Loebel A. Major depressive disorder with subthreshold hypomania (mixed features): Clinical characteristics of patients entered in a multiregional, placebo-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jul 4;68:9-14. doi: 10.1016/j.pnpbp.2016.02.007. Epub 2016 Feb 22.
Other Identifiers
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D1050304
Identifier Type: -
Identifier Source: org_study_id
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