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Showing 1–24 of 59 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Lurasidone HCl Clear all
Completed Phase 3 Interventional Results available

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

NCT01575561
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
Lurasidone
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years and older
Enrollment
377 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
25
States / cities
Dothan, Alabama • Glendale, California • Los Angeles, California + 22 more
Source: ClinicalTrials.gov public record
Updated Aug 21, 2016 · Synced Sep 2, 2026, 11:05 AM EDT
Withdrawn Phase 3 Interventional

Major Depressive Disorder With Mixed Features

NCT01423240
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Lurasidone 20 mg, Lurasidone 60 mg, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012
U.S. locations
27
States / cities
Birmingham, Alabama • Imperial, California • National City, California + 21 more
Source: ClinicalTrials.gov public record
Updated Dec 12, 2012 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

NCT00615433
View directory record Official record
Conditions
Schizophrenia
Interventions
Lurasidone, Olanzapine, Placebo comparator, Lurasidone 40 mg tablets
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
478 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
25
States / cities
Little Rock, Arkansas • Cerritos, California • Oceanside, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2015 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 1 Interventional Results available

Lurasidone Pediatric Pharmacokinetics Study

NCT01620060
View directory record Official record
Conditions
Schizophrenia, Autism
Interventions
Lurasidone
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
6 Years to 17 Years
Enrollment
105 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
10
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Murrieta, California + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2016 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 1 Interventional

Midazolam Drug-Drug Interaction Study With Lurasidone HCl

NCT01082263
View directory record Official record
Conditions
Schizophrenia Patients
Interventions
Lurasidone HCl
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
1
States / cities
Culver City, California
Source: ClinicalTrials.gov public record
Updated Sep 7, 2011 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 4 Interventional Results available

Lurasidone Effects on Tissue Glutamate in Schizophrenia

NCT02199743
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder
Interventions
Lurasidone, Haloperidol, Perphenazine
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 65 Years
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Feb 28, 2021 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

NCT00868699
View directory record Official record
Conditions
Bipolar Depression
Interventions
lurasidone, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
505 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
22
States / cities
Escondido, California • Garden Grove, California • Oceanside, California + 18 more
Source: ClinicalTrials.gov public record
Updated Apr 16, 2014 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 2Phase 3 Interventional

NRX101 Glx Biomarker Validation Study

NCT03402152
View directory record Official record
Conditions
Bipolar Depression, Suicidal Ideation
Interventions
NRX-101, Lurasidone HCl, Placebo
Drug
Lead sponsor
NeuroRx, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 8, 2022 · Synced Sep 2, 2026, 11:05 AM EDT
Not listed Phase 4 Interventional

Treatment Study Comparing Aripiprazole Once Monthly With Standard of Care Medication in Outpatients With Schizophrenia

NCT02282085
View directory record Official record
Conditions
Schizophrenia
Interventions
Aripiprazole Once-Monthly, Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)
Drug
Lead sponsor
Matt Byerly
Other
Eligibility
18 Years to 60 Years
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2014
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jun 7, 2015 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 2Phase 3 Interventional

NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

NCT03395392
View directory record Official record
Conditions
Bipolar Depression, Suicidal Ideation and Behavior
Interventions
NRX-101, Lurasidone HCl
Drug
Lead sponsor
NeuroRx, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
74 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
14
States / cities
Culver City, California • Miami Lakes, Florida • Atlanta, Georgia + 10 more
Source: ClinicalTrials.gov public record
Updated May 7, 2024 · Synced Sep 2, 2026, 11:05 AM EDT
Completed No phase listed Observational

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

NCT01431326
View directory record Official record
Conditions
Adenovirus, Anesthesia, Anxiety, Anxiolysis, Autism, Autistic Disorder, Bacterial Meningitis, Bacterial Septicemia, Benzodiazepine, Bipolar Disorder, Bone and Joint Infections, Central Nervous System Infections, Convulsions, Cytomegalovirus Retinitis, Early-onset Schizophrenia Spectrum Disorders, Epilepsy, General Anesthesia, Gynecologic Infections, Herpes Simplex Virus, Infantile Hemangioma, Infection, Inflammation, Inflammatory Conditions, Intra-abdominal Infections, Lower Respiratory Tract Infections, Migraines, Pain, Pneumonia, Schizophrenia, Sedation, Seizures, Skeletal Muscle Spasms, Skin and Skin-structure Infections, Treatment-resistant Schizophrenia, Urinary Tract Infections, Withdrawal, Sepsis, Gram-negative Infection, Bradycardia, Cardiac Arrest, Cardiac Arrhythmia, Staphylococcal Infections, Nosocomial Pneumonia, Neuromuscular Blockade, Methicillin Resistant Staphylococcus Aureus, Endocarditis, Neutropenia, Headache, Fibrinolytic Bleeding, Pulmonary Arterial Hypertension, CMV Retinitis, Hypertension, Chronic Kidney Diseases, Hyperaldosteronism, Hypokalemia, Heart Failure, Hemophilia, Heavy Menstrual Bleeding, Insomnia
Interventions
The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
Drug
Lead sponsor
Daniel Benjamin
Other
Eligibility
Up to 21 Years
Enrollment
3,520 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2019
U.S. locations
43
States / cities
Anchorage, Alaska • Little Rock, Arkansas • La Jolla, California + 37 more
Source: ClinicalTrials.gov public record
Updated Sep 5, 2023 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

Lurasidone Low-Dose - High-Dose Study Study

NCT01821378
View directory record Official record
Conditions
Schizophrenia
Interventions
Lurasidone, Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
412 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
28
States / cities
Little Rock, Arkansas • Cerritos, California • Escondido, California + 22 more
Source: ClinicalTrials.gov public record
Updated Jul 20, 2016 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 4 Interventional Results available

High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia

NCT01569659
View directory record Official record
Conditions
Schizophrenia
Interventions
Lurasidone
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years to 60 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
2
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Feb 27, 2025 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

Pediatric Open-Label Extension Study

NCT01914393
View directory record Official record
Conditions
Schizophrenia, Autism, Bipolar Depression
Interventions
Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
6 Years to 17 Years
Enrollment
702 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
35
States / cities
Dothan, Alabama • Downey, California • San Francisco, California + 31 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2019 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

Lurasidone Pediatric Autism Study

NCT01911442
View directory record Official record
Conditions
Autism
Interventions
Lurasidone 20 mg daily, Lurasidone, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
6 Years to 17 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
41
States / cities
Dothan, Alabama • Phoenix, Arizona • Newport Beach, California + 38 more
Source: ClinicalTrials.gov public record
Updated Feb 24, 2016 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 2 Interventional Results available

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

NCT03557931
View directory record Official record
Conditions
Schizophrenia
Interventions
ASP4345, placebo, risperidone, quetiapine, olanzapine, ziprasidone, aripiprazole, brexpiprazole, paliperidone, lurasidone
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
233 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
27
States / cities
Cerritos, California • Garden Grove, California • Lemon Grove, California + 19 more
Source: ClinicalTrials.gov public record
Updated Nov 11, 2024 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

NCT00868959
View directory record Official record
Conditions
Bipolar Depression
Interventions
lurasidone
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
817 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
58
States / cities
Little Rock, Arkansas • Anaheim, California • Chino, California + 49 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2016 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

Pediatric Schizophrenia Efficacy and Safety Study

NCT01911429
View directory record Official record
Conditions
Schizophrenia
Interventions
Lurasidone 40 mg, Lurasidone 80 mg, Placebo 40 or 80 mg
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
327 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
36
States / cities
Dothan, Alabama • Anaheim, California • Bakersfield, California + 33 more
Source: ClinicalTrials.gov public record
Updated Apr 17, 2017 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

NCT00549718
View directory record Official record
Conditions
Schizophrenia
Interventions
Lurasidone HCl
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
489 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
21
States / cities
Little Rock, Arkansas • Cerritos, California • Costa Mesa, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jun 10, 2014 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 2 Interventional Results available

Sequential Therapy for the Treatment of Severe Bipolar Depression.

NCT02974010
View directory record Official record
Conditions
Bipolar Depression, Suicidal Ideas, Suicidal Ideation, Suicide, Attempted
Interventions
NRX-101 Oral Capsule, Lurasidone Oral Capsule, Ketamine Intravenous Infusion, Saline Solution Intravenous Infusion
Drug
Lead sponsor
NeuroRx, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
4
States / cities
Birmingham, Alabama • Fort Lauderdale, Florida • Charlotte, North Carolina + 1 more
Source: ClinicalTrials.gov public record
Updated May 24, 2021 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

NCT00549666
View directory record Official record
Conditions
Pharmacokinetics
Interventions
Lurasidone 40 mg, Placebo 40 mg, Ortho Tri-Cyclen
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 40 Years · Female only
Enrollment
23 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Sep 13, 2011 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 3 Interventional Results available

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

NCT01284517
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lurasidone, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
356 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
22
States / cities
Costa Mesa, California • Riverside, California • San Diego, California + 16 more
Source: ClinicalTrials.gov public record
Updated Nov 25, 2013 · Synced Sep 2, 2026, 11:05 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Rifampin Drug-Drug Interaction Study With Lurasidone HCl

NCT01082276
View directory record Official record
Conditions
Male, Healthy Normal Subjects
Interventions
Lurasidone HCl
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 45 Years · Male only
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Sep 7, 2011 · Synced Sep 2, 2026, 11:05 AM EDT
Terminated Phase 4 Interventional

An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine

NCT05741502
View directory record Official record
Conditions
Treatment-resistant Schizophrenia
Interventions
Clozapine, Antipsychotics,Other (non-Clozapine)
Drug
Lead sponsor
Ohio State University
Other
Eligibility
18 Years to 65 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 24, 2026 · Synced Sep 2, 2026, 11:05 AM EDT