67 completed, 4 terminated, 4 unknown, 3 not yet recruiting. 38 Phase 3, 14 Phase 4, 12 Phase 1, 10 Phase 2, 2 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Broadband Near Infrared Spectroscopy to Understand the Role of Brain Cytochrome C Oxidase in Bipolar Disorder Lurasidone (Latuda) - Bipolar Disorder Depression | Phase 4 | Not yet recruiting | Martin Lan | 60 | 2026-11-01 | 2026-09-08 |
| Study of Lurasidone as Adjunctive Treatment in Patients With Major Depressive Disorder With Inadequate Response to Antidepressant Monotherapy Lurasidone, Placebo, Background Antidepressant Therapy - Major Depressive Disorder (MDD), Major Depressive Disorder With Psychotic Features | Phase 3 | Not yet recruiting | Bukwang Pharmaceutical | 364 | 2026-09-28 | 2026-09-16 |
| Single Day of Ultra-accelerated TMS With a Single Dose of NRX-101 TMS, NRX-101 - Major Depression | Early Phase 1 | Not yet recruiting | Mclean Hospital | 30 | 2026-09-01 | 2026-09-22 |
| Sequential Multiple Assignment Randomized Trial for Bipolar Depression Cariprazine, Aripiprazole/Escitalopram combination, Quetiapine - Bipolar I Disorder, Depression | Phase 4 | Active not recruiting | Massachusetts General Hospital | 2726 | 2024-10-01 | 2025-12-16 |
| Body Weight Changes After Switching to Lurasidone for Antipsychotic-induced Weight Gain in Bipolar Disorder Lurasidone - Bipolar Disorder (BD) | Completed | Dong-Wook Kim | 155 | 2024-09-09 | 2026-10-05 | |
| Sleep Quality, Cognitive Performance, and Computerized Cognitive Training Lurasidone, FDA Approved antidepressant treatment - Bipolar Disorder, Major Depressive Disorder | Withdrawn | George West Mental Health Foundation d/b/a Skyland Trail | 2024-04-15 | 2025-05-04 | ||
| NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone)) - Urinary Tract Infections, Pyelonephritis | Phase 2 | Unknown | NeuroRx, Inc. | 13 | 2024-03-31 | 2023-11-13 |
| An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine Clozapine, Antipsychotics,Other (non-Clozapine) - Treatment-resistant Schizophrenia | Phase 4 | Terminated | Ohio State University | 5 | 2023-08-16 | 2026-02-25 |
| Lurasidone Non-Interventional Study in Schizophrenia Patients Lurasidone - Schizophrenia | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A | 61 | 2022-10-21 | 2024-08-01 | |
| NRX-101 for Bipolar Depression With Subacute Suicidal Ideation NRX-101, Lurasidone HCl - Bipolar Depression, Suicidal Ideation and Behavior | Phase 2 / Phase 3 | Completed | NeuroRx, Inc. | 74 | 2022-05-12 | 2024-05-08 |
| Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU) Lurasidone - Schizophrenia | Phase 4 | Unknown | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | 10 | 2022-01-26 | 2023-03-17 |
| The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine Lurasidone - Schizophrenia | Phase 4 | Terminated | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | 13 | 2021-12-30 | 2024-04-19 |
| Chinese Longitudinal and Systematic Study of Bioplar Disorder Escitalopram Oxalate Tablets, Quetiapine Fumarate Tablets, Lurasidone - Major Depressive Disorder, Bipolar Disorder, Mixed | Not applicable | Recruiting | First Affiliated Hospital of Zhejiang University | 10000 | 2021-11-01 | 2022-10-17 |
| The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia Lurasidone - Schizophrenia | Phase 4 | Completed | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | 200 | 2021-08-16 | 2024-04-18 |
| A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression Lurasidone HCl, Placebo - Bipolar I Depression | Phase 3 | Terminated | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | 124 | 2020-12-11 | 2023-01-17 |
| The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients Lurasidone HCl - Schizophrenia | Completed | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | 3192 | 2020-12-01 | 2024-04-18 | |
| Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia" Lurasidone, aripiprazole, olanzapine, quetiapine or risperidone - Schizophrenia | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A | 95 | 2020-07-13 | 2023-05-06 | |
| NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation NRX-101, Lurasidone HCl - Bipolar Depression, Suicidal Ideation | Phase 3 | Unknown | NeuroRx, Inc. | 72 | 2019-12-01 | 2024-01-19 |
| 18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder Lurasidone - Bipolar Depression | Phase 4 | Completed | New York State Psychiatric Institute | 1 | 2019-02-07 | 2023-11-13 |
| NRX101 Glx Biomarker Validation Study NRX-101, Lurasidone HCl, Placebo - Bipolar Depression, Suicidal Ideation | Phase 2 / Phase 3 | Completed | NeuroRx, Inc. | 8 | 2018-11-01 | 2022-08-09 |
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Schizophrenia (44) · Bipolar Disorder (26) · Depression (9) · Psychotic Disorders (8) · Depressive Disorder, Major (6) · Autistic Disorder (5) · Suicidal Ideation (4) · Mood Disorders (2) · Schizophrenia, Treatment-Resistant (2) · Urinary Tract Infections (2) · Adenoviridae Infections (1) · Anxiety Disorders (1) · Arrhythmias, Cardiac (1) · Asperger Syndrome (1) · Behavior (1)
Sumitomo Pharma America, Inc. (37) · Marubeni Pharmaceuticals (Suzhou) Co., Ltd. (7) · NeuroRx, Inc. (5) · Sumitomo Pharma Co., Ltd. (5) · Aziende Chimiche Riunite Angelini Francesco S.p.A (2) · Bukwang Pharmaceutical (2) · Massachusetts General Hospital (2) · New York State Psychiatric Institute (2) · All India Institute of Medical Sciences, Bhubaneswar (1) · Astellas Pharma Global Development, Inc. (1) · Daniel Benjamin (1) · Dong-Wook Kim (1) · First Affiliated Hospital of Zhejiang University (1) · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (1) · George West Mental Health Foundation d/b/a Skyland Trail (1)
United States (58) · Russia (16) · Ukraine (14) · France (12) · Japan (10) · Slovakia (10) · India (9) · Romania (9) · China (8) · Colombia (8) · South Korea (8) · Canada (7) · Czechia (7) · Malaysia (7) · Poland (7)
Marina Bussel, MD (3) · ChaoYing Hu, MD (2) · Linmarie Sikich, MD (2) · Martin Brecher, MD (2) · Martin Lan, MD PhD (2) · Andrew A Nierenberg, MD (1) · Andrew Nierenberg, MD (1) · Ben W Hunter, MD (1) · Carol A Tamminga, M.D. (1) · Chi Hornik, PharmD (1) · Christoph Correll, MD (1)
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R01MH080270 (1), R21MH142900 (1)