Drugs / Lithium
last change Jan 2026 re-read 8 days ago

Lithium

targets BDNF, CDK5, GSK3B via activation / inhibition

Developed for
bipolar disorder · major depressive disorder · depressive disorder · bipolar depression · schizophrenia · bipolar I disorder · cognitive impairment with or without cerebellar ataxia · dementia
+27 more · manic bipolar affective disorder · cognitive disorder · small cell lung carcinoma · Alzheimer disease · amyotrophic lateral sclerosis · bipolar II disorder · Canavan disease · cannabis dependence · colorectal neoplasm · conduct disorder · corticobasal degeneration disorder · gastric neoplasm · Huntington disease · long COVID-19 · medullary thyroid gland carcinoma · mental disorder · neoplasm of esophagus · neuroendocrine neoplasm · osteoporosis-pseudoglioma syndrome · Parkinson disease · progressive supranuclear palsy · schizoaffective disorder · substance withdrawal syndrome · acute kidney injury · mood disorder · psychotic disorder · spinal cord injury
Investigated by
National Institute of Mental Health (NIMH) · New York State Psychiatric Institute · AstraZeneca · National Institute of Neurological Disorders and Stroke (NINDS) · Nova Scotia Health Authority · Assistance Publique - Hôpitaux de Paris
+101 more · Central South University · Dr. Inge Winter · Federal University of Rio Grande do Sul · Indiana University · Melbourne Health · National Institutes of Health (NIH) · State University of New York at Buffalo · University of Münster · University of Oxford · University of Sao Paulo · University of Wisconsin, Madison · Washington University School of Medicine · Aalborg University Hospital · Abbott · Agency for Healthcare Research and Quality (AHRQ) · Air Force Military Medical University, China · Angelini Pharma · Ariel Gildengers, MD · Barwon Health · Cancer Trials Ireland · CellPrint Biotechnology · Centre for Addiction and Mental Health · Children's Hospital Medical Center, Cincinnati · Chinese Academy of Sciences · Chonnam National University Hospital · Corning Hospital, Shenzhen City · Creighton University · Deakin University · Drexel University · Emory University · European Leukodystrophy Association · Ewha Womans University · Fight AIDS and Infectious Diseases Foundation · First Affiliated Hospital Xi'an Jiaotong University · First Affiliated Hospital of Kunming Medical University · German Federal Ministry of Education and Research · GlaxoSmithKline · Glostrup University Hospital, Copenhagen · Guiyun Xu · Hannover Medical School · Hospital de Clinicas de Porto Alegre · Icahn School of Medicine at Mount Sinai · James Murrough · K. Lieb · Karuna Therapeutics, Inc. · Keming Gao · Lawson, William B., M.D., PhD, DFAPA · Massachusetts General Hospital · Mediolanum Cardio Research · Mental Health Department Odense, University Clinic · National Alliance for Research on Schizophrenia and Depression · National Cancer Institute (NCI) · National Center for Advancing Translational Sciences (NCATS) · National Institute on Aging (NIA) · National Institute on Drug Abuse (NIDA) · Northwell Health · Patient-Centered Outcomes Research Institute · Peking University Sixth Hospital · Peter MacCallum Cancer Centre, Australia · Pfizer · Psychiatric Center Copenhagen, Rigshospitalet · Psychiatric Hospital, Hillerod · Rakitzi, Stavroula · Region Stockholm · Renmin Hospital of Wuhan University · Rigshospitalet, Denmark · Second Military Medical University · Seventh People's Hospital of Hangzhou · Shandong Mental Health Center · Shanghai Jiao Tong University School of Medicine · Shanghai Mental Health Center · Shanxi Medical University · Shire · Soon Chun Hyang University · all 107 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) LITHIUM CITRATE — 1980-12-23 fda.gov ↗

Trials 80 · started per year

today
US approved 1980
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1980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05923476 Jun 2023 → May 2025 depressive disorder Melbourne Health Unknown No outcome recorded
Phase 19 trials
Phase 1 NCT06993662 Jun 2025 → Dec 2027 expected anxiety, bipolar disorder, depressive disorder, obsessive-compulsive disorder +3 Rakitzi, Stavroula Active not recruiting No outcome recorded
Phase 1 NCT06729970 Dec 2024 → Jan 2026 — Karuna Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT03153280 Jan 2022 → Sep 2023 colorectal neoplasm, gastric neoplasm, neoplasm of esophagus Cancer Trials Ireland Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT04273932 Oct 2019 → Jun 2023 Parkinson disease State University of New York at Buffalo Completed No outcome recorded
Phase 1 NCT01565759 May 2012 → May 2023 disease by molecular mechanism Nova Scotia Health Authority Completed No outcome recorded
Phase 1 NCT00820794 May → Jun 2009 generalized anxiety disorder Pfizer Withdrawn No outcome recorded
Phase 1 NCT01074073 Aug → Oct 2008 schizophrenia Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 1 NCT00548964 Oct 2007 → Jul 2013 major depressive disorder James Murrough Completed No outcome recorded
Phase 1 NCT00563992 Jan 2001 → Sep 2008 bipolar disorder New York State Psychiatric Institute Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT01553916 Apr 2012 → Sep 2016 small cell lung carcinoma Washington University School of Medicine Completed No outcome recorded
Phase 1/2 NCT00703677 Sep 2008 → Jan 2010 corticobasal degeneration disorder, progressive supranuclear palsy Westat Completed No outcome recorded
Phase 1/2 NCT00581009 May 2001 → Dec 2011 bipolar disorder, major depressive disorder University of California, Irvine Completed No outcome recorded
Phase 211 trials · 1 missed
Phase 2 NCT06051240 Feb 2024 → Aug 2030 expected brain neoplasm, cognitive disorder, radiation-induced disorder Region Stockholm Recruiting No outcome recorded
Phase 2 NCT05618587 Nov 2022 → Jul 2023 long COVID-19 State University of New York at Buffalo Completed Missed primary
Phase 2 NCT01880593 Jul 2013 → Nov 2016 depressive disorder Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 2 NCT01768767 Jan 2013 bipolar depression Yale University Withdrawn No outcome recorded Stop: Business
Phase 2 NCT00657748 Sep 2009 → Sep 2010 Canavan disease, nutritional deficiency disease Assistance Publique - Hôpitaux de Paris Withdrawn No outcome recorded
Phase 2 NCT00925847 Jun 2009 → Apr 2011 amyotrophic lateral sclerosis Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 2 NCT00582712 Jan 2008 → May 2009 medullary thyroid gland carcinoma University of Wisconsin, Madison Terminated No outcome recorded Stop: Business
Phase 2 NCT00501540 Jul 2007 → Jun 2009 neuroendocrine neoplasm University of Wisconsin, Madison Completed No outcome recorded
Phase 2 NCT00114439 Sep 2005 → Sep 2006 cannabis dependence, substance withdrawal syndrome Sydney South West Area Health Service Completed No outcome recorded
Phase 2 NCT00095355 Oct 2004 → Mar 2005 Huntington disease National Institute of Neurological Disorders and Stroke (NINDS) Completed No outcome recorded
Phase 2/32 trials · 1 missed
Phase 2/3 NCT01928446 Jul 2015 → Aug 2019 bipolar disorder, depressive disorder VA Office of Research and Development Terminated Missed primary
Phase 2/3 NCT00080158 Mar 2004 → Jun 2007 depressive disorder New York State Psychiatric Institute Completed No outcome recorded
Phase 310 trials · 1 missed
Phase 3 NCT05603104 Apr 2025 → Jun 2028 expected bipolar depression, major depressive disorder, schizophrenia Dr. Inge Winter Recruiting No outcome recorded
Phase 3 NCT05973786 Feb 2025 → Jun 2028 expected bipolar depression Dr. Inge Winter Recruiting No outcome recorded
Phase 3 NCT02374567 Jan 2015 → Jun 2017 anxiety disorder, dementia, depressive disorder, schizophrenia +1 Hannover Medical School Terminated No outcome recorded
Phase 3 NCT00883493 Apr 2009 → Mar 2011 bipolar depression AstraZeneca Completed No outcome recorded
Phase 3 NCT00400088 Jun 2007 → Jan 2013 major depressive disorder Nova Scotia Health Authority Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT00448578 Aug 2005 → Jun 2006 manic bipolar affective disorder AstraZeneca Completed No outcome recorded
Phase 3 NCT00074776 May 2003 → Oct 2007 bipolar disorder Stanford University Completed Missed primary
Phase 3 NCT00226135 Mar 2001 → Dec 2006 bipolar disorder University of Aarhus Completed No outcome recorded
Phase 3 NCT00221429 Mar 2001 → Aug 2006 bipolar disorder Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
Phase 3 NCT00000385 Sep 1997 → Dec 2003 conduct disorder Drexel University Completed No outcome recorded
Phase 434 trials · 1 met primary · 3 missed
Phase 4 NCT06662526 Nov 2024 → Nov 2029 expected bipolar disorder, dementia, major depressive disorder University of Chile Not yet recruiting No outcome recorded
Phase 4 NCT06184581 May 2024 → Dec 2027 expected bipolar II disorder University Hospital Bispebjerg and Frederiksberg Recruiting No outcome recorded
Phase 4 NCT05913947 Dec 2022 → Sep 2028 expected bipolar depression Aalborg University Hospital Recruiting No outcome recorded
Phase 4 NCT05531591 Aug 2019 → Jul 2024 cognitive impairment with or without cerebellar ataxia, dementia, major depressive disorder Centre for Addiction and Mental Health Completed No outcome recorded
Phase 4 NCT03185208 Feb 2018 → Aug 2024 cognitive impairment with or without cerebellar ataxia Ariel Gildengers, MD Completed No outcome recorded
Phase 4 NCT03219008 Aug 2017 → Dec 2019 major depressive disorder Shanghai Mental Health Center Unknown Missed primary
Phase 4 NCT03210480 Mar 2017 → Sep 2019 bipolar disorder Angelini Pharma Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT02960763 Feb 2017 → Sep 2020 major depressive disorder Washington University School of Medicine Completed Mixed
Phase 4 NCT02909504 Sep 2016 → Nov 2018 bipolar disorder Keming Gao Terminated No outcome recorded Stop: Business
Phase 4 NCT01543724 Jun 2015 → Dec 2017 bipolar disorder Ewha Womans University Withdrawn No outcome recorded Stop: Enrollment
Phase not applicable10 trials
— NCT06054321 Aug 2022 → Dec 2028 expected major depressive disorder Chonnam National University Hospital Recruiting No outcome recorded
— NCT04218981 Jan 2020 → Jun 2023 mental disorder Central South University Completed No outcome recorded
— NCT02601859 Aug 2016 → Jun 2017 cognitive impairment with or without cerebellar ataxia University of Dundee Completed No outcome recorded
— NCT01486459 Nov 2012 → Aug 2014 small cell lung carcinoma Barwon Health Terminated No outcome recorded Stop: Enrollment
— NCT01880957 Nov 2011 → Jun 2017 bipolar depression, major depressive disorder Stony Brook University Completed No outcome recorded
— NCT03965247 Oct 2011 → Sep 2012 — University of Oxford Completed No outcome recorded
— NCT01431573 Jul 2011 → Aug 2016 bipolar disorder, major depressive disorder New York State Psychiatric Institute Completed No outcome recorded
— NCT01463111 May 2011 → Apr 2016 bipolar disorder Emory University Completed No outcome recorded
— NCT01108068 Jul 2010 → Jul 2014 osteoporosis-pseudoglioma syndrome University of Maryland, Baltimore Completed No outcome recorded
— NCT00012558 Sep 1998 → Sep 2005 bipolar disorder National Institute of Mental Health (NIMH) Completed Mixed
Comparator or background therapy47 trials
Phase 1 NCT00437385 Background Mar 2005 → Mar 2010 major depressive disorder Charite University, Berlin, Germany Completed No outcome recorded
Phase 1/2 NCT01046786 Comparator Jan 2010 → Oct 2013 spinal cord injury China Spinal Cord Injury Network Completed No outcome recorded
Phase 1/2 NCT00612807 Background Jul 2006 → Jun 2010 major depressive disorder Duke University Completed No outcome recorded
Phase 2 NCT03290963 Comparator Nov 2017 → Dec 2018 — William V. Bobo, M.D. Withdrawn No outcome recorded
Phase 2 NCT02129348 Comparator Jun 2014 → Jan 2020 Alzheimer disease, psychotic disorder New York State Psychiatric Institute Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 128 sources stand behind the page.

FieldValueCited text
Known as Lithium “The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil) antidepressants (SSRI, SNRI), mood stabilizers (lithium, depakine), antipsychotics (clozapine and...” NCT06993662 ↗
126

“An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).” NCT00857584 ↗

“Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID).” NCT01074073 ↗

“300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment” NCT00820794 ↗

“In case of relapse Bupropion, Quetiapine, Lithium or Aripiprazole might be add-on.” NCT06467474 ↗

“Lithium (according to response, serum levels, and tolerance) 150-1500mg” NCT01000402 ↗

“Choose lithium or valproate for bipolar disorder group” NCT04218981 ↗

“augmentation with mood stabilizer (lithium)” NCT06054321 ↗

“Lithium: 200-1200 mg/d. 905AN01” NCT01305707 ↗

“Lithium” NCT03056248 ↗

NCT00254488 ↗

Show 116 more sources

Known as lithium aspartate “INTERVENTION: Lithium aspartate, 10 to 15 mg/d, or identically appearing placebo for 3 weeks followed by open-label lithium aspartate, 10 to 15 mg/d, for 2 weeks.” PMID 39356507 ↗ Oct 2024
Known as Lithium Carbonate “Drug: Lithium Carbonate” NCT00602537 ↗
3

“Drug: Lithium Carbonate” NCT01565759 ↗

“Drug: Lithium Carbonate” NCT00501540 ↗

“Drug: Lithium Carbonate” NCT00870311 ↗

Known as Lithium sulphate ClinicalTrials.gov intervention name — accepted as the source's own label NCT03210480 ↗
Known as Lithobid, lithium carbonate “Lithobid, lithium carbonate” NCT01431573 ↗
Action Activate “It is hypothesized that at safe and tolerable doses these drugs will enhance depleted levels of brain-derived neurotrophic factor (BDNF)” NCT00095355 ↗
Route Oral “Tablets, Oral, once daily” NCT00261443 ↗
Target BDNF “Lithium carbonate, a drug used to treat bipolar disorder, and divalproex, a drug used to treat mood disorders and seizure disorders, have both been shown to increase the amount...” NCT00095355 ↗