Drugs / Lithium
Lithium
also known as
Lithium Carbonate · lithium aspartate · Lithium sulphate · Lithobid, lithium carbonate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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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Also used as a comparator or background therapy in 47 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00437385 Background | Mar 2005 → Mar 2010 | major depressive disorder | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| 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 22 trials | ||||||
| Phase 2 | NCT03290963 Comparator | Nov 2017 → Dec 2018 | — | William V. Bobo, M.D. | Withdrawn | No outcome recorded |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 |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01166425 Comparator | Jun 2010 → Apr 2013 | bipolar I disorder | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT06929273 Background | Jul 2025 → Jun 2028 expected | bipolar I disorder | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT00857584 Background | May 2009 → Feb 2011 | bipolar depression | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00868452 Comparator | Apr 2009 → Dec 2011 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00665366 Comparator | Jun 2008 → Oct 2011 | manic bipolar affective disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00114686 Background | Jan 2006 → Apr 2007 | alcohol dependence, bipolar I disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00266630 Background | Nov 2005 → May 2009 | manic bipolar affective disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00183443 Comparator | Feb 2005 → Nov 2010 | bipolar disorder, schizophrenia | Palo Alto Veterans Institute for Research | Completed | No outcome recorded |
| Phase 3 | NCT00107731 Background | Apr 2004 → Oct 2006 | bipolar I disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00081380 Background | Mar 2004 → Sep 2006 | bipolar disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01977300 Background | Jan 2003 → Aug 2011 | bipolar I disorder | University of British Columbia | Completed | No outcome recorded |
| Phase 3 | NCT00221975 Comparator | Jul 2002 → Jun 2007 | bipolar disorder | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00063362 Background | Feb 2002 → Jul 2007 | bipolar disorder | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded |
| Phase 3 | NCT00194129 Background | Nov 1997 → Sep 2006 | bipolar disorder | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00518947 Comparator | Nov 1994 → Jun 1999 | manic bipolar affective disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 421 trials | ||||||
| Phase 4 | NCT07047651 Background | Jun 2025 → Dec 2027 expected | treatment-refractory schizophrenia | Dr. Stavroula Rakitzi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03056248 Comparator | Apr → Dec 2017 | acute kidney injury | Lifespan | Unknown | No outcome recorded |
| Phase 4 | NCT03004521 Comparator | Nov 2016 → Apr 2021 | mood disorder | King's College London | Unknown | No outcome recorded |
| Phase 4 | NCT02287259 Comparator | Nov 2014 → Mar 2019 | bipolar disorder | Tadashi Hasegawa | Completed | No outcome recorded |
| Phase 4 | NCT01938859 Background | Jun 2012 → Dec 2017 | bipolar disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT01526148 Comparator | Jan 2012 → Jan 2015 | bipolar disorder | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT01588457 Comparator | Jun 2011 → Dec 2016 | bipolar I disorder, bipolar II disorder | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 4 | NCT01254721 Comparator | Dec 2010 → Oct 2012 | manic bipolar affective disorder | AstraZeneca | Terminated | No outcome recorded |
| Phase 4 | NCT02870283 Comparator | May 2010 → Nov 2014 | bipolar disorder | Federal University of Rio Grande do Sul | Completed | No outcome recorded |
| Phase 4 | NCT01134731 Comparator | May 2010 → Feb 2014 | major depressive disorder | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT01028508 Comparator | Jan 2010 → Sep 2015 | depressive disorder | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT00961961 Background | Jul 2009 → Sep 2016 | bipolar disorder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT01305707 Comparator | Jul 2009 → Jul 2014 | major depressive disorder | Hospital Universitari de Bellvitge | Terminated | No outcome recorded |
| Phase 4 | NCT00931723 Comparator | Jun 2009 → Nov 2010 | manic bipolar affective disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00926835 Comparator | May 2009 → May 2015 | major depressive disorder | Ministry of Health & Welfare, Korea | Terminated | No outcome recorded |
| Phase 4 | NCT00976794 Background | Jan 2009 → Jun 2012 | bipolar I disorder | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT00627887 Background | Jan 2008 → May 2012 | major depressive disorder | Örebro County Council | Completed | No outcome recorded |
| Phase 4 | NCT00602537 Comparator | Dec 2007 → Jun 2013 | bipolar disorder, depressive disorder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT00261443 Background | Sep 2005 → Jun 2009 | bipolar disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01191918 Comparator | May 2005 → Apr 2008 | manic bipolar affective disorder | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT00048802 Background | Aug 2002 → Aug 2006 | bipolar disorder | Northwell Health | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT06467474 Background | Mar 2024 → Jun 2025 overdue | major depressive disorder | Ricardo Alberto Moreno, M.D., Ph.D. | Recruiting | No outcome recorded |
| — | NCT06751875 Comparator | Jul 2019 → Dec 2024 | major depressive disorder | University of Antwerp | Completed | No outcome recorded |
| — | NCT02039479 Comparator | Jan 2014 → Mar 2018 | depressive disorder | Technical University Dresden | Unknown | No outcome recorded |
| — | NCT01896349 Background | Apr 2013 → Aug 2014 | — | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT00893581 Comparator | Mar 2009 → Feb 2016 | manic bipolar affective disorder | University of Cincinnati | Completed | No outcome recorded |
| — | NCT00520026 Comparator | Jan 2001 → Jun 2006 | depressive disorder | University Hospital Schleswig-Holstein | Terminated | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2011-02-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | ABILIFY (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or ValproateData from 52-week maintenance trial showed superiority of adjunctive ABILIFY versus adjunctive placebo on primary study endpoint® otsuka.co.jp ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 128 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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” NCT01565759 ↗3“Drug: Lithium Carbonate” NCT00501540 ↗ “Drug: Lithium Carbonate” NCT00870311 ↗ “Drug: Lithium Carbonate” NCT00602537 ↗ |
| 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 ↗ |