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ClinicalTrials.gov public records Last synced Sep 30, 2026, 6:59 PM EDT

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Showing 25–48 of 60 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Lurasidone HCl Clear all
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 8, 2011 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 1 Interventional

The Bioequivalence Of Two Different Lurasidone Formulations In Patients

NCT01082250
View directory record Official record
Conditions
Schizophrenia
Interventions
Lurasidone HCl
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated Sep 8, 2011 · Synced Sep 30, 2026, 6:59 PM 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 8, 2024 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

NCT01082146
View directory record Official record
Conditions
Pharmacokinetics, Metabolism
Interventions
Lurasidone
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 45 Years · Male only
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Apr 3, 2014 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 2 Interventional Results available

A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

NCT00088621
View directory record Official record
Conditions
Schizophrenia
Interventions
Lurasidone 80mg tablet
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 64 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
21
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Cerritos, California + 16 more
Source: ClinicalTrials.gov public record
Updated Apr 17, 2014 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 4 Interventional Results available

18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder

NCT03902613
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lurasidone
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 50 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Nov 13, 2023 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 4 Interventional Results available

Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics

NCT00806234
View directory record Official record
Conditions
Psychotic Disorders
Interventions
Aripiprazole or Perphenazine, Metformin, Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
8 Years to 19 Years
Enrollment
127 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2014
U.S. locations
4
States / cities
Baltimore, Maryland • Glen Oaks, New York • Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Apr 25, 2017 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 3 Interventional Results available

Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

NCT00789698
View directory record Official record
Conditions
Chronic Schizophrenia
Interventions
Lurasidone HC1, Quetiapine XR
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
240 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
27
States / cities
Little Rock, Arkansas • Cerritos, California • Costa Mesa, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jun 12, 2015 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 3 Interventional Results available

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

NCT01143090
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder
Interventions
Lurasidone HCl
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years and older
Enrollment
149 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2010
U.S. locations
27
States / cities
Little Rock, Arkansas • Escondido, California • Garden Grove, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jun 12, 2015 · Synced Sep 30, 2026, 6:59 PM 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 13, 2012 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 3 Interventional Results available

Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

NCT00641745
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder
Interventions
Lurasidone HCl, Risperidone
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
629 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
41
States / cities
Little Rock, Arkansas • Anaheim, California • Cerritos, California + 34 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2015 · Synced Sep 30, 2026, 6:59 PM 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 14, 2011 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 1 Interventional Results available

A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia

NCT03627195
View directory record Official record
Conditions
Schizophrenia
Interventions
DSP-1349M, placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Long Beach, California
Source: ClinicalTrials.gov public record
Updated May 8, 2020 · Synced Sep 30, 2026, 6:59 PM EDT
Not yet recruiting Early Phase 1 Interventional

Single Day of Ultra-accelerated TMS With a Single Dose of NRX-101

NCT07785102
View directory record Official record
Conditions
Major Depression
Interventions
TMS, NRX-101
Device · Drug
Lead sponsor
Mclean Hospital
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Belmont, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 22, 2026 · Synced Sep 30, 2026, 6:59 PM 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 17, 2014 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 1 Interventional

Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl

NCT01074632
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
Interventions
Lurasidone HCl
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009
U.S. locations
2
States / cities
Glendale, California • Wichita, Kansas
Source: ClinicalTrials.gov public record
Updated Sep 8, 2011 · Synced Sep 30, 2026, 6:59 PM 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 18, 2017 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 3 Interventional Results available

Major Depressive Disorder With Mixed Features - Extension

NCT01423253
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Lurasidone
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
17
States / cities
Birmingham, Alabama • Escondido, California • Garden Grove, California + 13 more
Source: ClinicalTrials.gov public record
Updated Apr 8, 2016 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 4 Interventional Results available

NMDA Antagonists in Bipolar Depression

NCT01833897
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Standard of Care, Ketamine, D-cycloserine
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 1, 2016 · Synced Sep 30, 2026, 6:59 PM EDT
Not listed Phase 3 Interventional

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation

NCT03396068
View directory record Official record
Conditions
Bipolar Depression, Suicidal Ideation
Interventions
NRX-101, Lurasidone HCl
Drug
Lead sponsor
NeuroRx, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
4
States / cities
Birmingham, Alabama • Hollywood, Florida • Fort Worth, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 19, 2024 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 3 Interventional

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

NCT02731612
View directory record Official record
Conditions
Bipolar Disorder
Interventions
lurasidone, Placebo
Drug · Other
Lead sponsor
Lakshmi N Yatham
Other
Eligibility
19 Years to 65 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
2
States / cities
Boston, Massachusetts • Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 14, 2025 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 3 Interventional Results available

Lurasidone Pediatric Bipolar Study

NCT02046369
View directory record Official record
Conditions
Bipolar I Depression
Interventions
Lurasidone, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
30
States / cities
Dothan, Alabama • Culver City, California • Hartford, Connecticut + 27 more
Source: ClinicalTrials.gov public record
Updated Dec 20, 2017 · Synced Sep 30, 2026, 6:59 PM EDT
Completed Phase 3 Interventional Results available

Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.

NCT00790192
View directory record Official record
Conditions
Schizophrenia
Interventions
Lurasidone, Quetiapine XR, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
488 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
29
States / cities
Little Rock, Arkansas • Cerritos, California • Costa Mesa, California + 23 more
Source: ClinicalTrials.gov public record
Updated Mar 17, 2016 · Synced Sep 30, 2026, 6:59 PM EDT
Active, not recruiting Phase 4 Interventional

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

NCT06433635
View directory record Official record
Conditions
Bipolar I Disorder, Depression
Interventions
Cariprazine, Aripiprazole/Escitalopram combination, Quetiapine, Lurasidone
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 75 Years
Enrollment
2,726 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
17
States / cities
Birmingham, Alabama • Bloomington, Indiana • Baltimore, Maryland + 13 more
Source: ClinicalTrials.gov public record
Updated Dec 16, 2025 · Synced Sep 30, 2026, 6:59 PM EDT