Clinical Trials
Numerous clinical trials evaluate the therapeutic applications and physiological effects of lithium carbonate across phases ranging from Early Phase 1 to Phase 4. While the majority focus on psychiatric conditions such as major depressive disorder, bipolar disorder, and suicidal ideation, others investigate non-psychiatric indications including acute kidney injury and spinal cord injuries. Sponsored by academic medical centers and pharmaceutical companies, these protocols span various recruitment statuses, including active, recruiting, completed, terminated, and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07750925 | NOT_YET_RECRUITING | Healthy; Bipolar |
Northumbria University |
2026-08-01 | |
| NCT06184581 | RECRUITING | Bipolar II Disorder |
University Hospital Bispebjerg and Frederiksberg |
2024-05-08 | PHASE4 |
| NCT06776848 | RECRUITING | Proven Pathogenic or Probably Pathogenic TBR1 Variant |
Centre Hospitalier Universitaire Dijon |
2025-09-12 | PHASE1; PHASE2 |
| NCT05814640 | RECRUITING | Depression; Sequestra |
First Affiliated Hospital of Chongqing Medical University |
2023-02-20 | PHASE1; PHASE2 |
| NCT07540338 | RECRUITING | Bipolar I Disorder |
Alzamend Neuro, Inc. |
2026-05-11 | PHASE1; PHASE2 |
| NCT05593627 | UNKNOWN | Heart Valve Surgery |
China Medical University, China |
2023-07-01 | PHASE4 |
| NCT06921590 | COMPLETED | Pharmacokinetics; Neurology |
Alzamend Neuro, Inc. |
2025-05-09 | PHASE1 |
| NCT06008249 | TERMINATED | Amyotrophic Lateral Sclerosis |
Stichting TRICALS Foundation |
2021-08-09 | PHASE3 |
| NCT06789783 | RECRUITING | Cornelia De Lange Syndrome |
University of Milan |
2024-05-01 | PHASE2; PHASE3 |
| NCT05126238 | TERMINATED | Carotid Artery Diseases; Carotid Artery Stenosis |
Negovsky Reanimatology Research Institute |
2021-11-20 | PHASE3 |
| NCT06861842 | ACTIVE_NOT_RECRUITING | Healthy; Healthy Donors |
Centro de Atencion e Investigacion Medica |
2024-06-01 | PHASE4 |
| NCT06719544 | COMPLETED | Healthy |
Merck Sharp & Dohme LLC |
2025-01-02 | PHASE1 |
| NCT02999022 | UNKNOWN | Fractures |
Sunnybrook Health Sciences Centre |
2017-07-21 | PHASE2 |
| NCT05402891 | COMPLETED | Familial Adenomatous Polyposis |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2022-06-02 | PHASE2 |
| NCT04623398 | COMPLETED | Autism Spectrum Disorder |
Assistance Publique - Hôpitaux de Paris |
2022-02-21 | PHASE3 |
| NCT03185208 | COMPLETED | Mild Cognitive Impairment |
Ariel Gildengers, MD |
2018-02-02 | PHASE4 |
| NCT06396312 | Recruiting | Depressive; Disorder Major Single Episode Major With Psychotic Symptoms|Depressive; Disorder Major Single Episode Major (Without Psychotic Symptoms)|Depressive Disorder Major Recurrent With Psychotic Symptoms|Depressive Disorder Major Recurrent Without Psychotic Symptoms|Depressive Disorder Treatment-Resistant Class I or II|Depressive Disorder Major Moderate|Depressive Disorder Major Severe |
Max-Planck-Institute of Psychiatry |
2024-04-02 | -- |
| NCT06134349 | Recruiting | Bipolar Disorder |
Leiden University Medical Center |
2024-03-13 | -- |
| NCT01669369 | UNKNOWN | Osteosarcoma |
Sun Yat-sen University |
2013-01 | PHASE4 |
| NCT05982340 | Recruiting | Acute Kidney Injury Due to Sepsis|Proximal Tubule Function|Lithium Clearance |
University Hospital of North Norway |
2023-08-01 | -- |
| NCT01565759 | COMPLETED | Drug Mechanism |
Nova Scotia Health Authority |
2012-05-05 | PHASE1 |
| NCT05044611 | Recruiting | Bipolar Disorder |
Assistance Publique - Hôpitaux de Paris |
2023-01-11 | Phase 4 |
| NCT05648435 | Completed | Acute Kidney Injury |
University Hospital of North Norway |
2022-12-07 | -- |
| NCT02862210 | COMPLETED | Frontotemporal Dementia (FTD) |
Columbia University |
2017-01-27 | PHASE2 |
| NCT05221593 | COMPLETED | Neutropenia |
Al-Azhar University |
2020-08-01 | PHASE3 |
| NCT04479566 | COMPLETED | Sleep Deprivation |
China Medical University, China |
2020-11-06 | PHASE4 |
| NCT04222816 | COMPLETED | Bipolar Affective Disorder |
All India Institute of Medical Sciences, Bhubaneswar |
2020-01-16 | PHASE4 |
| NCT04826510 | UNKNOWN | Depressive Disorder |
Shanghai Mental Health Center |
2020-11-25 | PHASE4 |
| NCT03201627 | UNKNOWN | Niemann-Pick Disease, Type C1 |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
2017-07-05 | EARLY_PHASE1 |
| NCT03210480 | TERMINATED | Bipolar Disorder |
Aziende Chimiche Riunite Angelini Francesco S.p.A |
2017-03-28 | PHASE4 |
| NCT03148535 | UNKNOWN | the Use of Antidepressants in Patients With Bipolar Depression |
Peking University |
2017-06-01 | PHASE4 |
| NCT02039479 | UNKNOWN | Suicidal Ideation/Behavior; Depression |
Technische Universität Dresden |
2014-01 | |
| NCT03056248 | UNKNOWN | Acute Kidney Injury |
Lifespan |
2017-04-01 | PHASE4 |
| NCT01112813 | COMPLETED | Stroke |
Sunnybrook Health Sciences Centre |
2010-04 | PHASE3 |
| NCT02601859 | COMPLETED | Mild Cognitive Impairment |
University of Dundee |
2016-08 | |
| NCT01553916 | COMPLETED | Small Cell Lung Carcinoma |
Washington University School of Medicine |
2012-04-26 | PHASE1; PHASE2 |
| NCT02198859 | COMPLETED | Prostate Cancer |
University of Kansas Medical Center |
2014-04 | PHASE1 |
| NCT01820624 | COMPLETED | Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia |
Paolo Caimi, MD |
2013-04-30 | PHASE1 |
| NCT01259388 | COMPLETED | Multiple Sclerosis |
VA Office of Research and Development |
2011-05 | PHASE1; PHASE2 |
| NCT01855594 | COMPLETED | Neuropathic Pain; Neuralgia; Spinal Cord Injuries |
China Spinal Cord Injury Network |
2013-05 | PHASE2 |
| NCT02918097 | COMPLETED | Bipolar Disorder |
Federal University of Rio Grande do Sul |
2010-05 | PHASE4 |
| NCT01108068 | COMPLETED | Osteoporosis Pseudoglioma |
University of Maryland, Baltimore |
2010-07 | |
| NCT01105702 | TERMINATED | Brain Cancer |
NYU Langone Health |
2010-05 | PHASE2 |
| NCT00240110 | COMPLETED | Bipolar Disorder; Cocaine Dependence |
University of Miami |
2006-03 | PHASE1; PHASE2 |
| NCT01754883 | WITHDRAWN | Combat Posttraumatic Stess Disorder; Mild Traumatic Brain Injury |
VA Eastern Colorado Health Care System |
2011-01 | PHASE1 |
| NCT01471613 | COMPLETED | Spinal Cord Injury |
China Spinal Cord Injury Network |
2011-09 | PHASE1; PHASE2 |
| NCT01354483 | COMPLETED | Spinal Cord Injuries |
China Spinal Cord Injury Network |
2011-09 | PHASE1; PHASE2 |
| NCT00602537 | COMPLETED | Bipolar Disorder; Depression |
University of Pennsylvania |
2007-12 | PHASE4 |
| NCT01166425 | COMPLETED | Bipolar Disorder |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2010-06 | PHASE2; PHASE3 |
| NCT01096082 | COMPLETED | Spinocerebellar Ataxia Type 3; Machado Joseph Disease |
Hospital de Clinicas de Porto Alegre |
2011-05 | PHASE2; PHASE3 |
| NCT00998634 | COMPLETED | SPINOCEREBELLAR ATAXIA 2 |
Federico II University |
2009-10 | PHASE2 |
| NCT00276965 | COMPLETED | Bipolar Disorder; Depression |
Lindner Center of HOPE |
2006-09 | PHASE3 |
| NCT00251316 | COMPLETED | Thyroid Cancer; Differentiated Thyroid Carcinoma |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2005-11 | PHASE2 |
| NCT00997672 | TERMINATED | Multiple System Atrophy |
Federico II University |
2009-10 | PHASE2 |
| NCT00883493 | COMPLETED | Acute Bipolar Depression |
AstraZeneca |
2009-04 | PHASE3 |
| NCT01189812 | COMPLETED | Major Depressive Disorder; Dysthymia; Depression Not Otherwise Specified; Borderline Personality Disorder |
Columbia Northwest Pharmaceuticals |
2010-03 | PHASE2 |
| NCT00408681 | COMPLETED | Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Atypical Chronic Myeloid Leukemia, Breakpoint Cluster Region-abl Translocation (BCR-ABL) Negative; Blastic Phase Chronic Myelogenous Leukemia; Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Acute Myeloid Leukemia in Remission; Childhood Chronic Myelogenous Leukemia; Childhood Myelodysplastic Syndromes; Chronic Eosinophilic Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; de Novo Myelodysplastic Syndromes; Disseminated Neuroblastoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Gastrointestinal Complications; Juvenile Myelomonocytic Leukemia; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Poor Prognosis Metastatic Gestational Trophoblastic Tumor; Previously Treated Childhood Rhabdomyosarcoma; Primary Myelofibrosis; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Malignant Testicular Germ Cell Tumor; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Neuroblastoma; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Small Lymphocytic Lymphoma; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Splenic Marginal Zone Lymphoma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage II Ovarian Epithelial Cancer; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Chronic Lymphocytic Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Malignant Testicular Germ Cell Tumor; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Multiple Myeloma; Stage III Ovarian Epithelial Cancer; Stage III Small Lymphocytic Lymphoma; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Breast Cancer; Stage IV Chronic Lymphocytic Leukemia; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Ovarian Epithelial Cancer; Stage IV Small Lymphocytic Lymphoma |
Fred Hutchinson Cancer Center |
2006-06 | |
| NCT00750061 | COMPLETED | Spinal Cord Injury |
China Spinal Cord Injury Network |
2008-08 | PHASE2 |
| NCT00667745 | COMPLETED | Bipolar Disorder |
National Institute of Mental Health (NIMH) |
2008-04 | PHASE4 |
| NCT00790582 | COMPLETED | Amyotrophic Lateral Sclerosis |
Forbes Norris MDA/ALS Research Center |
2008-05 | PHASE2 |
| NCT00683943 | COMPLETED | Spinocerebellar Ataxia Type I |
National Institute of Neurological Disorders and Stroke (NINDS) |
2008-05-18 | PHASE1 |
| NCT00431171 | COMPLETED | Spinal Cord Injuries |
The University of Hong Kong |
2007-09 | PHASE1 |
| NCT00818389 | TERMINATED | Amyotrophic Lateral Sclerosis |
Massachusetts General Hospital |
2009-01 | PHASE2; PHASE3 |
| NCT00789854 | COMPLETED | Major Depressive Disorder; Treatment Resistant Depression |
AstraZeneca |
2008-11 | PHASE3 |
| NCT00501540 | COMPLETED | Neuroendocrine Tumors |
University of Wisconsin, Madison |
2007-07 | PHASE2 |
| NCT00582712 | TERMINATED | Medullary Thyroid Cancer |
University of Wisconsin, Madison |
2008-01 | PHASE2 |
| NCT00442039 | COMPLETED | Bipolar I Disorder Without Psychotic Symptoms |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2006-12 | PHASE2 |
| NCT00469937 | TERMINATED | Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Neurotoxicity; Solid Tumor |
Vanderbilt-Ingram Cancer Center |
2006-02 | PHASE1 |
| NCT01055392 | UNKNOWN | Cognitive Impairment; Alzheimer Disease |
University of Sao Paulo |
2007-03 | PHASE2 |
| NCT00057681 | COMPLETED | Bipolar Disorder |
Washington University School of Medicine |
2003-02 | PHASE3 |
| NCT00202306 | COMPLETED | Schizophrenia; Bipolar Disorder; Psychotic Disorders |
Melbourne Health |
2001-11 | PHASE4 |
| NCT00641927 | COMPLETED | Bipolar Type II Disorder |
Stanley Medical Research Institute |
2002-04 | PHASE4 |
| NCT00870311 | COMPLETED | Bipolar Disorder |
Wayne State University |
1996-03 | PHASE4 |
| NCT00602394 | COMPLETED | Bipolar Disorder |
Roxane Laboratories |
2003-05 | |
| NCT00601536 | COMPLETED | Bipolar Disorder |
Roxane Laboratories |
2003-04 | |
| NCT00602381 | COMPLETED | Bipolar Disorder |
Roxane Laboratories |
2002-11 | |
| NCT00601575 | COMPLETED | Bipolar Disorder |
Roxane Laboratories |
2002-10 | |
| NCT00422331 | UNKNOWN | Bipolar Disorder; Mania |
JDS Pharmaceuticals |
2007-01 | PHASE3 |
| NCT00485680 | COMPLETED | Bipolar Disorder |
Eli Lilly and Company |
2003-12 | PHASE3 |
| NCT00000369 | COMPLETED | Bipolar Disorder |
University of Pittsburgh |
1997-06 | PHASE3 |
| NCT00177567 | COMPLETED | Bipolar Disorder |
University of Pittsburgh |
2001-07 | PHASE4 |
| NCT00114439 | COMPLETED | Cannabis Dependence; Substance Withdrawal Syndrome |
Sydney South West Area Health Service |
2005-09 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-06)
Check the
Lithium carbonate
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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Note: Technical data last updated: Sep 1, 2026.