CLINICAL TRIALS PROFILE FOR LITHANE

All Clinical Trials for LITHANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00400088 ↗	Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide	Terminated	Nova Scotia Health Authority	Phase 3	2007-06-01	This study is being done to look at how well people respond to two very different drug treatments for depression. Clinically, people with depression can respond differently to drug treatments for reasons which are not always clear. Some of our own recent research suggests that people with depression who have a family history of bipolar disorder or completed suicide, may react differently to standard antidepressant medications than those without such a family history. Our data shows that family history of completed suicide, as well as the known predictor of family history of bipolar disorder, may help identify a pre-bipolar high risk group i.e. they currently have depression but at some future date will declare a bipolar illness (manic-depression) by virtue of development of a manic episode also. Our research suggests that treatment- emergent symptoms in response to a trial of antidepressant, such as agitation may be strong predictors of future bipolarity and inherently dangerous particularly as they are not ascribed to the antidepressant treatment. Finally, it is possible that this subgroup of those with depressive illness may respond better and more safely to lithium, a mood stabiliser used in known bipolar depression. The objective of this proposal is to investigate response to acute lithium treatment in subjects who meet the diagnostic criteria for major depression, but who are potentially at risk for bipolar disorder, by virtue of family history of bipolarity or completed suicide.
NCT00408681 ↗	Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant	Completed	National Cancer Institute (NCI)	N/A	2006-06-01	RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
NCT00408681 ↗	Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant	Completed	Fred Hutchinson Cancer Research Center	N/A	2006-06-01	RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
NCT00870311 ↗	Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients	Completed	National Institute of Mental Health (NIMH)	Phase 4	1996-03-01	This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.
NCT00870311 ↗	Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients	Completed	Wayne State University	Phase 4	1996-03-01	This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.

Clinical Trial Conditions for LITHANE

Condition Name

Condition Name for LITHANE
Intervention	Trials
Recurrent Childhood Acute Myeloid Leukemia	1
Stage III Adult Diffuse Small Cleaved Cell Lymphoma	1
Disseminated Neuroblastoma	1
Stage IV Small Lymphocytic Lymphoma	1

Condition MeSH

Condition MeSH for LITHANE
Intervention	Trials
Depressive Disorder	2
Depression	2
Bipolar Disorder	2
Leukemia, Myelomonocytic, Chronic	1

Clinical Trial Locations for LITHANE

Trials by Country

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−

Trials by Country for LITHANE
Location	Trials
United States	3
Canada	1

Trials by US State

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−

Trials by US State for LITHANE
Location	Trials
Minnesota	1
Michigan	1
Washington	1

Clinical Trial Progress for LITHANE

Clinical Trial Phase

Clinical Trial Phase for LITHANE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for LITHANE
Clinical Trial Phase	Trials
Completed	2
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for LITHANE

Sponsor Name

Sponsor Name for LITHANE
Sponsor	Trials
National Cancer Institute (NCI)	1
Fred Hutchinson Cancer Research Center	1
National Institute of Mental Health (NIMH)	1

Sponsor Type

Sponsor Type for LITHANE
Sponsor	Trials
Other	4
NIH	2

The Evolving Landscape of Lithium: Clinical Trials, Market Analysis, and Projections

Introduction to Lithium in Psychiatry

Lithium, a cornerstone in the treatment of various psychiatric disorders, has been a subject of continuous research and innovation. Recent developments, including new formulations and ongoing clinical trials, are set to transform the way lithium is used in clinical practice.

New Formulations of Lithium

LiProSal: A Safer and More Effective Lithium Formulation

A significant advancement in lithium therapy is the introduction of LiProSal, a new branded formulation that combines lithium with proline and salicylate (aspirin). This formulation, developed by Alzamend Pharmaceuticals, aims to enhance the safety and efficacy of lithium treatment. By facilitating higher therapeutic brain levels with lower serum levels, LiProSal reduces the risk of physical side effects, such as tremor and renal risks, by up to 20%[1].

Clinical Trials Update

LiProSal Clinical Trials

LiProSal is currently being evaluated in clinical trials for four potential indications: Alzheimer’s disease, PTSD, Major Depression, and Bipolar Disorder. The trials involve comparing LiProSal to traditional lithium formulations to assess its efficacy and safety. Patients in these trials take the standard market lithium for two weeks, followed by a washout period, and then switch to LiProSal. The primary focus is on measuring lithium levels in the brain to demonstrate the superiority of LiProSal[1].

Other Notable Clinical Trials in Psychiatry

While LiProSal is a promising development, other drugs are also making significant strides in psychiatric treatment. For example, CAPLYTA (lumateperone), used for schizophrenia and bipolar depression, has shown a 63% reduction in relapse risk compared to placebo in Phase 3 trials. This drug, developed by Intra-Cellular Therapies, has demonstrated strong efficacy and safety, positioning it as a competitive option against established antipsychotics[3].

Market Analysis of Lithium Drugs

Global Market Trends

The global lithium drug market is experiencing steady growth, driven by increasing cases of neurological and psychiatric disorders such as bipolar disorder, mania, and depression. The market is projected to grow at a CAGR of 4.30% from 2021 to 2028, with North America currently holding the largest market share due to a high prevalence of these disorders and significant healthcare expenditure[2].

Regional Market Insights

• North America: Dominates the market due to a rising population with bipolar and depressive disorders.
• Europe: Holds the second-largest market share, attributed to advanced medical facilities.
• Asia-Pacific: Expected to account for the largest market share in the coming years, driven by technological advancements and increasing healthcare expenditure[2].

Patient Epidemiology and Market Drivers

The growth of the lithium drug market is also influenced by the increasing geriatric population and rising cases of depression in females in developing countries. However, factors such as strict dose monitoring, the presence of alternative medications, and adverse drug reactions may pose challenges to market growth[2].

Pharmaceutical Grade Lithium Carbonate Market

Market Size and Forecast

The pharmaceutical grade lithium carbonate market is valued at USD 141 million in 2023 and is forecasted to reach USD 166 million by 2028, growing at a CAGR of 3.3%. This market is segmented by application, purity, and region, with key players including Livent Corporation, Albemarle Corporation, and Jiangsu Lianhuan Pharmaceutical Co., Ltd.[5].

Challenges and Opportunities

Safety and Efficacy Concerns

Traditional lithium formulations are associated with several side effects, including renal risks and tremors. The development of new formulations like LiProSal addresses these concerns by reducing serum levels while maintaining therapeutic efficacy. However, strict monitoring and adherence to dosage guidelines remain crucial[1].

Regulatory and Competitive Landscape

The lithium drug market is subject to regulatory changes and competitive pressures. New drugs like CAPLYTA and innovative formulations like LiProSal are expanding the treatment options available to patients, but they also face competition from established brands and alternative therapies[2][3].

Future Projections and Implications

Expanding Indications

The potential use of LiProSal in additional indications such as Alzheimer’s disease and PTSD could significantly expand its market reach. Successful clinical trials and regulatory approvals will be pivotal in this expansion[1].

Technological Advancements

Advancements in technology, particularly in drug delivery systems and formulation science, are expected to drive innovation in the lithium drug market. These advancements could lead to more efficient, safer, and more effective treatments[5].

Key Takeaways

• New Formulations: LiProSal is a promising new formulation that enhances the safety and efficacy of lithium treatment.
• Clinical Trials: Ongoing trials for LiProSal and other drugs like CAPLYTA are set to redefine treatment standards in psychiatry.
• Market Growth: The global lithium drug market is growing at a CAGR of 4.30%, driven by increasing cases of neurological disorders.
• Regional Insights: North America and Europe are significant markets, with Asia-Pacific expected to grow rapidly.
• Challenges and Opportunities: Addressing safety concerns and navigating regulatory and competitive landscapes are key to market success.

FAQs

What is LiProSal and how does it differ from traditional lithium?

LiProSal is a new formulation of lithium that combines lithium with proline and salicylate (aspirin), allowing for higher therapeutic brain levels with lower serum levels, thus reducing physical side effects.

What are the potential indications for LiProSal?

LiProSal is being developed for four potential indications: Alzheimer’s disease, PTSD, Major Depression, and Bipolar Disorder.

How is the global lithium drug market expected to grow?

The global lithium drug market is projected to grow at a CAGR of 4.30% from 2021 to 2028, driven by increasing cases of neurological and psychiatric disorders.

What are the key challenges facing the lithium drug market?

Challenges include strict dose monitoring, the presence of alternative medications, and adverse drug reactions.

Which regions are expected to dominate the lithium drug market in the future?

North America and Europe currently dominate, but the Asia-Pacific region is expected to account for the largest market share in the coming years due to technological advancements and increasing healthcare expenditure.

Sources

1. The Carlat Report: "A New Form of Lithium" - CARLAT PUBLISHING, January 7, 2024.
2. Data Bridge Market Research: "Global Lithium Drug Market" - Industry Trends and Forecast to 2028.
3. Stock Titan: "ITCI's CAPLYTA Shows Breakthrough 63% Reduction..." - November 5, 2024.
4. FDA: "Drug Trials Snapshot: LYBALVI" - September 19, 2023.
5. MarketsandMarkets: "Pharmaceutical Grade Lithium Carbonate Market" - March 20, 2024.