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
-

PEARL Schizophrenia Maintenance

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-09-19
Last Posted Date
2016-04-08
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
676
Registration Number
NCT01435928
Locations
🇺🇸

Lousiana Clinical Research, LLC, Shreveport, Louisiana, United States

🇺🇸

CRI Worldwide LLC, Willingboro, New Jersey, United States

🇺🇸

FutureSearch Clinical Trials, LP, Dallas, Texas, United States

and more 71 locations

Major Depressive Disorder With Mixed Features - Extension

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-08-25
Last Posted Date
2016-04-08
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
48
Registration Number
NCT01423253
Locations
🇺🇸

St. Charles Psychiatric Associates/Midwest Research Group, St. Charles, Missouri, United States

🇺🇸

Village Clinical Research Inc., New York, New York, United States

🇺🇸

Stanford -VA Palo Alto Health Care System, Palo Alto, California, United States

and more 14 locations

Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose

First Posted Date
2011-08-22
Last Posted Date
2016-07-15
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
211
Registration Number
NCT01421134
Locations
🇷🇸

Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic", Vrsac, Serbia

🇷🇸

Special Hospital for Psychiatric Diseases "Sveti Vracevi", Vojvodina, Serbia

🇺🇸

Clinical Innovations Inc., Riverside, California, United States

and more 39 locations

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-05-23
Last Posted Date
2016-09-07
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
965
Registration Number
NCT01358357
Locations
🇺🇸

AXIS Clinical Trials, Los Angeles, California, United States

🇺🇸

Harmonex Neuroscience Research, Dothan, Alabama, United States

🇺🇸

Behavioral Research Specialists, LLC, Glendale, California, United States

and more 101 locations

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-01-27
Last Posted Date
2013-11-26
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
356
Registration Number
NCT01284517
Locations
🇺🇸

Clinical Innovations, Inc., Costa Mesa, California, United States

🇺🇸

Clinical Innovations inc., Santa Ana, California, United States

🇺🇸

Collaborative Neuroscience Network, Torrance, California, United States

and more 72 locations

A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-06-14
Last Posted Date
2015-06-12
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
149
Registration Number
NCT01143090
Locations
🇺🇸

Comprehensive NeuroScience, Inc., Atlanta, Georgia, United States

🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

🇺🇸

FutureSearch Trials of Dallas, Dallas, Texas, United States

and more 24 locations

A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-06-14
Last Posted Date
2013-04-17
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
244
Registration Number
NCT01143077
Locations
🇺🇸

Collaborative Neuroscience Network, South Bay, Torrance, California, United States

🇺🇸

Comprehensive NeuroScience, Inc., Atlanta, Georgia, United States

🇺🇸

CRI Worldwide - Kirkbride Center, Philadelphia, Pennsylvania, United States

and more 24 locations

Rifampin Drug-Drug Interaction Study With Lurasidone HCl

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-03-08
Last Posted Date
2011-09-08
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
20
Registration Number
NCT01082276
Locations
🇺🇸

PAREXEL Clinical Pharmacology Research Unit, Baltimore, Maryland, United States

Midazolam Drug-Drug Interaction Study With Lurasidone HCl

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-03-08
Last Posted Date
2011-09-08
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
24
Registration Number
NCT01082263
Locations
🇺🇸

CCT/Parexel, Culver City, California, United States

The Bioequivalence Of Two Different Lurasidone Formulations In Patients

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-03-08
Last Posted Date
2011-09-08
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
52
Registration Number
NCT01082250
Locations
🇺🇸

California Clinical Trials (CCT), Glendale, California, United States

© Copyright 2024. All Rights Reserved by MedPath