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Lurasidone

Generic Name
Lurasidone
Brand Names
Latuda
Drug Type
Small Molecule
Chemical Formula
C28H36N4O2S
CAS Number
367514-87-2
Unique Ingredient Identifier
22IC88528T
Background

Lurasidone is an atypical antipsychotic developed by Dainippon Sumitomo Pharma. It was approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia on October 29, 2010 and is currently pending approval for the treatment of bipolar disorder in the United States.

Indication

Lurasidone is indicated for the treatment of schizophrenia in patients ≥13 years old. It is also indicated as a monotherapy for the treatment of bipolar depression in patients ≥10 years old, or in combination with lithium or valproate for the treatment of bipolar depression in adults.

Associated Conditions
Depression, Bipolar, Schizophrenia
Associated Therapies
-

Lurasidone and Cognition in Bipolar I Disorder

Phase 3
Completed
Conditions
Bipolar I Disorder
Interventions
First Posted Date
2014-05-26
Last Posted Date
2017-02-02
Lead Sponsor
University of British Columbia
Target Recruit Count
53
Registration Number
NCT02147379
Locations
🇨🇦

University of British Columbia, Department of Psychiatry, Vancouver, British Columbia, Canada

Lurasidone Pediatric Bipolar Study

Phase 3
Completed
Conditions
Bipolar I Depression
Interventions
Drug: Placebo
Drug: Lurasidone
First Posted Date
2014-01-27
Last Posted Date
2017-12-20
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
350
Registration Number
NCT02046369
Locations
🇺🇸

Psychiatric Associates, Overland Park, Kansas, United States

🇺🇸

University Hospitals Case Medical Center, Cleveland, Ohio, United States

🇺🇸

Harmonex Neuroscience Research, Dothan, Alabama, United States

and more 63 locations

Lurasidone Pediatric Autism Study

Phase 3
Completed
Conditions
Autism
Interventions
First Posted Date
2013-07-30
Last Posted Date
2016-02-25
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
150
Registration Number
NCT01911442
Locations
🇺🇸

Florida Clinical Research Center, LLC, Maitland, Florida, United States

🇺🇸

Institute for Behavioral Medicine, LLC, Smyrna, Georgia, United States

🇺🇸

Capstone Clinical Research, Inc., Libertyville, Illinois, United States

and more 35 locations

Lurasidone Low-Dose - High-Dose Study Study

First Posted Date
2013-04-01
Last Posted Date
2016-07-21
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
412
Registration Number
NCT01821378
Locations
🇺🇸

Center for Behavioral Health, LLC, Rockville, Maryland, United States

🇷🇴

Spitalul Universitar de Urgenta Militar Central "Dr Carol Davila", Bucuresti, Romania

🇷🇴

Spitalul Judetean de Urgenta "Sf. Pantelimon" Focsani, Focsani, Romania

and more 62 locations

Lurasidone Pediatric Pharmacokinetics Study

Phase 1
Completed
Conditions
Schizophrenia
Autism
Interventions
First Posted Date
2012-06-15
Last Posted Date
2016-04-08
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
105
Registration Number
NCT01620060
Locations
🇺🇸

Atlanta Center for Medical Research, Atlanta, Georgia, United States

🇺🇸

Woodland International Research Group, Inc., Little Rock, Arkansas, United States

🇺🇸

Woodland Northwest Research, LLC, Springdale, Arkansas, United States

and more 7 locations

This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

Phase 3
Completed
Conditions
Bipolar I Disorder
Interventions
First Posted Date
2012-04-11
Last Posted Date
2016-08-22
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
377
Registration Number
NCT01575561
Locations
🇺🇸

Atlanta Center for Medical Research, Atlanta, Georgia, United States

🇺🇸

Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center, Dallas, Texas, United States

🇵🇱

NZOZ BioMed, Kielce, Poland

and more 65 locations

High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia

Phase 4
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2012-04-03
Last Posted Date
2015-12-09
Lead Sponsor
Northwestern University
Target Recruit Count
101
Registration Number
NCT01569659
Locations
🇺🇸

Northwestern University Department of Psychiatry and Behavioral Sciences, Chicago, Illinois, United States

A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2012-03-29
Last Posted Date
2019-04-09
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
191
Registration Number
NCT01566162
Locations
🇺🇸

AXIS Clinical Trials, Los Angeles, California, United States

🇺🇸

CNRI-Los Angeles. LLC, Pico Rivera, California, United States

🇺🇸

Neuropsychiatric Research Center of Orange County, Santa Ana, California, United States

and more 59 locations

Lurasidone Extended Use Study

Phase 3
Completed
Conditions
Schizophrenia
Bipolar Disorder
Interventions
First Posted Date
2011-12-05
Last Posted Date
2016-11-04
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
162
Registration Number
NCT01485640
Locations
🇷🇴

Spitalul Clinic de Neuropsihiatrie Craiova, Craiova, Romania

🇨🇿

Psychiatricka ambulance, Brno-mesto, Czech Republic

🇨🇿

Vojenska nemocnice Olomouc, Olomouc, Czech Republic

and more 43 locations
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