Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
NCT ID: NCT01284517
Last Updated: 2013-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
356 participants
INTERVENTIONAL
2010-11-30
2012-08-31
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
TRIPLE
Study Groups
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Lurasidone 20-120 mg flexible dose
Lurasidone
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Placebo
Placebo
Equivalent to Lurasidone dosing
Interventions
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Lurasidone
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Placebo
Equivalent to Lurasidone dosing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
3. Has a lifetime history of at least one bipolar manic or mixed manic episode.
4. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
5. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
6. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
7. Good physical health on the basis of medical history, physical examination, and laboratory screening.
Exclusion Criteria
2. Any chronic organic disease of the CNS (other than Bipolar I Disorder).
3. Hospitalization for a manic or mixed episode within the past two months.
4. Used investigational compound within past 6 months.
5. Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.
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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Clinical Innovations, Inc.
Costa Mesa, California, United States
Clinical Innovations Inc.
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Clinical Innovations inc.
Santa Ana, California, United States
Collaborative Neuroscience Network
Torrance, California, United States
Colorado Clinical Trials Inc.
Highlands Ranch, Colorado, United States
Accurate Clinical Trials
Kissimmee, Florida, United States
Clinical Neuroscience Solutions Inc.
Orlando, Florida, United States
Northwest Behavioral Research Center
Roswell, Georgia, United States
Institute for Behavioral Medicine LLC
Smyrna, Georgia, United States
Precise Research Centers
Flowood, Mississippi, United States
Village Clinical Research Inc.
New York, New York, United States
Medical & Behavioral Health Research
New York, New York, United States
Zarzar Psychiatric Associates, PLLC
Raleigh, North Carolina, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Clinical Trials, LP
Dallas, Texas, United States
Pillar Clinical Research
Dallas, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Clinical Research Group Edmonton Inc
Edmonton, Alberta, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Pierre-Janet Hospital
Gatineau, Quebec, Canada
Hopital Louis-H Lafontaine
Montreal, Quebec, Canada
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, , Colombia
Centro de Investigacion y Atencion para la Salud Mental
Bogotá, , Colombia
CISNE - UIC Campo Abierto
Bogotá, , Colombia
Hospital Mental de Antioquia
Cali, , Colombia
Psychiatricka ambulance
Brno-mesto, , Czechia
Vojenska nemocnice Olomouc
Olomouc, , Czechia
Clintrial, s.r.o.
Prague, , Czechia
Psychiatry Trial s.r.o.
Prague, , Czechia
Brain Mind Behavior Neuroscience Research Institute
Visakhapatnam, Andh Prad, India
Shanti Nursing Home
Kanchanpalli, Aurangabad, Maharashtra, India
SBKS Medical College and Hospital, Brij Psychiatry Hospital
Vadodara, Gujarat, India
Abhaya Hospital Psychiatry
Bangalore, Karna, India
K.S. Hegde Medical Academy
Mangalore, Karna, India
Poona Hospital & Research Center
Pune, Mahara, India
Mahatma Ghandi Institute of Medical Sciences
Wardha, Mahara, India
Mental Health Care & Research
Jaipur, Rajasthan, India
R.K. Yadav Memorial Mental Health & De-addiction Hospital
Jaipur, Rajasthan, India
Mahendru Psychiatric Center
Kanpur, Uttar Prad, India
Chatrapati Shau Maharaj Medical University
Lucknow, Utter Prad, India
Ongata Hospital
Hachioji-shi, , Japan
Kohnodai Hospital, National Center for Global Health & Medicine
Ichikawa, , Japan
National Hospital Organization Hizen Psychiatric Center
Kanzaki-gun, , Japan
National Center of Neurology & Psychiatry
Kodaira-shi, , Japan
Asakayama General Hospital
Sakaishi, , Japan
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
Takatsuki, , Japan
Neuromeda JSC
Kaunas, , Lithuania
Ziegzdriai Mental Hospital, Public Institution
Kaunas, , Lithuania
Silutes Mental Health & Psychtherapy Center, JSC
Šilutė, , Lithuania
Seskines Outpatient Clinic, Public Institution
Vilnius, , Lithuania
Zirmunai Mental Health Center, Public Institution
Vilnius, , Lithuania
Hospital Nacional Arzobispo Loayza
Lima, , Peru
Hospital Nacional Hipolito Unanue
Lima, , Peru
Clinica Vesalio
Lima, , Peru
Centrum zdravia R. B. K. s.r.o.
Bardejov, , Slovakia
Bojniciach
Bojnice, , Slovakia
Psychiatricka ambulancia Mentum s.r.o.
Bratislava, , Slovakia
FNsP Bratislava, Nemocnica Ruzinov
Bratislava, , Slovakia
Nemocnica s poliklinikou Liptovsky Milulas
Liptovský Mikuláš, , Slovakia
PsychoLine s.r.o.
Rimavská Sobota, , Slovakia
Nemocnica s poliklikou Sv. Barbory
Rožňava, , Slovakia
Pro mente sana
Trenčín, , Slovakia
Kherson Regional Psychiatric Hospital
Kherson, Vil Stepanivka, Ukraine
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, , Ukraine
Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
Dnipropetrovsk, , Ukraine
St. In. Inst of Neurol, Psych, and Narcol of the AMSU
Kharkiv, , Ukraine
Kyiv City Psychoneurological Hospital #2
Kyiv, , Ukraine
Lviv Regional Clinical Psychiatric Hospital
Lviv, , Ukraine
Ternopil Regional Municipal Dispensary, Narcology Dept.
Ternopil, , Ukraine
Zapor. Reg. CI Hospital, Zaporizhzhia SMU
Zaporizhzhya, , Ukraine
Countries
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References
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Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.
Suppes T, Kroger H, Pikalov A, Loebel A. Lurasidone adjunctive with lithium or valproate for bipolar depression: A placebo-controlled trial utilizing prospective and retrospective enrolment cohorts. J Psychiatr Res. 2016 Jul;78:86-93. doi: 10.1016/j.jpsychires.2016.03.012. Epub 2016 Mar 31.
Other Identifiers
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2010-019778-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1050292
Identifier Type: -
Identifier Source: org_study_id