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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

Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients

Phase 3
Completed
Conditions
Bipolar Disorder
Interventions
Other: Placebo
First Posted Date
2016-04-07
Last Posted Date
2025-02-14
Lead Sponsor
Lakshmi N Yatham
Target Recruit Count
100
Registration Number
NCT02731612
Locations
🇺🇸

The Brigham and Women's Hospital, Department of Psychiatry, Boston, Massachusetts, United States

🇺🇸

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

🇨🇦

UBC Mood Disorders Center, Vancouver, British Columbia, Canada

and more 6 locations

Biosignatures of Latuda for Bipolar Depression

Not Applicable
Completed
Conditions
Bipolar Depression
Interventions
First Posted Date
2014-09-12
Last Posted Date
2017-12-12
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
20
Registration Number
NCT02239094
Locations
🇺🇸

New York State Psychiatric Institute, New York, New York, United States

Lurasidone Effects on Tissue Glutamate in Schizophrenia

Phase 4
Completed
Conditions
Schizophrenia
Schizoaffective Disorder
Interventions
First Posted Date
2014-07-24
Last Posted Date
2021-03-01
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
35
Registration Number
NCT02199743
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

Phase 1
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2014-06-25
Last Posted Date
2019-01-11
Lead Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
Target Recruit Count
37
Registration Number
NCT02174510
Locations
🇨🇳

Xuhui Center Hospital, Shanghai, Shanghai, China

Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects

Phase 1
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2014-06-25
Last Posted Date
2019-04-08
Lead Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
Target Recruit Count
14
Registration Number
NCT02174523
Locations
🇨🇳

Xuhui Center Hospital, Shanghai, Shanghai, China

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
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

A Clinical Trial of Lurasidone in Treatment of Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2013-12-06
Last Posted Date
2019-11-15
Lead Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
Target Recruit Count
388
Registration Number
NCT02002832
Locations
🇨🇳

Guangzhou Brain Hospital, Guangzhou, Guangdong, China

🇨🇳

HeBei Mental Health Center, Baoding, Hebei, China

🇨🇳

Tianjin Anding Hospital, Tianjin, Tianjin, China

and more 12 locations

A Phase III Study of SM-13496 in Patients With Bipolar I Depression.

Phase 3
Completed
Conditions
Bipolar Depression
Interventions
Drug: Placebo
First Posted Date
2013-11-18
Last Posted Date
2022-04-12
Lead Sponsor
Sumitomo Pharma Co., Ltd.
Target Recruit Count
525
Registration Number
NCT01986101
Locations
🇯🇵

Japan 76 sites, Tokyo, Japan

🇱🇹

Lithuania 3 sites, Kaunas, Lithuania

🇲🇾

Malaysia 5 sites, Kuala Lumpur, Malaysia

and more 5 locations

A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

Phase 3
Completed
Conditions
Bipolar I Disorder
Interventions
First Posted Date
2013-11-18
Last Posted Date
2022-04-12
Lead Sponsor
Sumitomo Pharma Co., Ltd.
Target Recruit Count
495
Registration Number
NCT01986114
Locations
🇺🇦

Ukraine 9 sites, Kiev, Ukraine

🇸🇰

Slovakia 5 sites, Zilina, Slovakia

🇲🇾

Malaysia 5 sites, Kuala Lumpur, Malaysia

and more 5 locations
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