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Lithium Sulphate, Anhydrous

This article explores the use of Lithium Sulphate, Anhydrous in clinical trials, specifically focusing on its potential to prevent cognitive impairment in children who have undergone brain tumor radiotherapy. The LiBRA study aims to assess the efficacy of lithium treatment in preserving cognitive processing speed and other neuropsychological functions in young patients who have received cranial or craniospinal radiation treatment.

Table of Contents

What is Lithium Sulphate?

Lithium sulphate, anhydrous is a medication that is being studied for its potential to prevent cognitive impairment in children who have undergone brain tumor radiotherapy. It is also known by the brand name Lithionit and is classified as a type of medication called lithium[1].

Lithium is typically used to treat mood disorders, but researchers are now exploring its potential benefits for protecting the brain after radiation treatment. The medication comes in the form of a prolonged-release tablet, which means it releases the active ingredient slowly over time[1].

Purpose of the Study

The main goal of this study, called LiBRA (Lithium treatment to prevent cognitive impairment after brain radiotherapy), is to see if lithium treatment can help prevent cognitive problems in children who have received radiation therapy for brain tumors[1].

Specifically, the researchers want to find out if lithium can prevent a decrease in cognitive processing speed. This refers to how quickly a person can understand and react to information[1].

Who Can Participate?

The study is looking for participants who meet certain criteria:

  • Children between 5 and 18 years old
  • Have received radiation treatment for a brain tumor within the last 7 years
  • Are able to use proper birth control methods during the study and for 6 months after
  • Have permission from their parents or caregivers to participate[1]

Some conditions that would prevent a child from participating include:

  • Allergies to lithium
  • Kidney problems
  • Heart diseases
  • Uncontrolled thyroid problems
  • Pregnancy or breastfeeding
  • Severe imbalances in body fluids or electrolytes[1]

What the Study Involves

Participants in the study will receive lithium sulphate treatment. The medication is given as a tablet that slowly releases the drug over time. The maximum daily dose is 336 mg, and the treatment may last up to 6 months[1].

Throughout the study, researchers will conduct various tests to measure the effects of the treatment:

  1. Cognitive tests: These will assess things like processing speed, memory, and problem-solving skills.
  2. Quality of life questionnaires: To understand how the treatment affects overall well-being.
  3. Brain scans (MRI): To look at changes in brain structure and function.

These tests will be done before starting treatment and at various points during and after treatment, up to 5 years later[1].

Potential Benefits

If successful, this study could show that lithium treatment helps prevent cognitive problems in children who have had brain radiation. This could lead to improved quality of life and better long-term outcomes for these young patients[1].

Important Considerations

It’s important to note that this is a research study, and the benefits of lithium for this purpose are not yet proven. Like all medications, lithium can have side effects and risks. The study team will closely monitor participants for any problems[1].

If you or your child are interested in participating in this study, it’s crucial to discuss it thoroughly with your healthcare provider. They can help you understand the potential risks and benefits and determine if it might be appropriate for your situation[1].

Aspect Details
Study Name LiBRA – Lithium treatment to prevent cognitive impairment after brain radiotherapy
Main Objective Assess efficacy of lithium in preventing cognitive processing speed impairment in children after CNS radiotherapy
Participant Age Range 5 to 18 years at time of radiotherapy
Treatment Duration Maximum 6 months
Primary Endpoint Difference in Processing Speed Index (PSI) from baseline to two years later
Secondary Endpoints Changes in neuropsychological test scores, quality of life measures, and brain MRI findings
Drug Information Lithionit 42 mg (6 mmol) prolonged-release tablet, containing Lithium Sulphate, Anhydrous
Administration Route Oral use
Maximum Daily Dose 336 mg

FAQ

  • What is the main goal of the LiBRA clinical trial? The main goal of the LiBRA clinical trial is to assess the effectiveness of lithium treatment in preventing late-appearing cognitive processing speed impairment (PSI) in children who have undergone brain radiotherapy for central nervous system (CNS) malignancies.
  • Who is eligible to participate in this clinical trial? Eligible participants are children aged 5 to 18 years who have received cranial or craniospinal radiation treatment for a brain tumor within the last 7 years. They must also meet other specific criteria, including adequate contraception and negative pregnancy tests for applicable patients.
  • What are some of the exclusion criteria for the trial? Some exclusion criteria include allergy to lithium, renal failure, cardiac failure or heart disease, uncontrolled hypothyroidism, pregnancy or breastfeeding, severe fluid or electrolyte imbalance, and a Karnofsky-Lansky score below 60.
  • How long does the lithium treatment last in this trial? The maximum treatment period for lithium in this trial is 6 months.
  • What are some of the secondary objectives of the study? Secondary objectives include assessing the efficacy of lithium treatment through evaluation of other neuropsychological test scores, examining radiological findings using MRI after lithium treatment, and exploring the feasibility of lithium treatment in this patient group.

Ongoing Clinical Trials on Lithium Sulphate, Anhydrous

  • Study on Lithium Sulphate to Prevent Cognitive Impairment in Children After Brain Tumor Radiotherapy

    Recruiting

    2 1 1
    Investigated drugs:
    Denmark Sweden

Glossary

  • CNS: Central Nervous System, which includes the brain and spinal cord.
  • Cognitive Processing Speed Impairment (PSI): A decline in the ability to quickly and accurately process information, which can affect various mental tasks.
  • Craniospinal radiation: A type of radiation therapy that targets both the brain and spine.
  • GFR: Glomerular Filtration Rate, a measure of kidney function.
  • Karnofsky-Lansky score: A scale used to measure a patient's overall performance status and ability to carry out daily activities.
  • MRI: Magnetic Resonance Imaging, a medical imaging technique used to create detailed images of the body's organs and tissues.
  • Neuropsychological test: A series of tests that assess various aspects of cognitive function, such as memory, attention, and problem-solving skills.
  • Processing Speed Index (PSI): A measure of cognitive efficiency, assessing how quickly a person can process and respond to information.
  • Volumetric measures: Measurements of the size or volume of specific brain structures, such as the hippocampus.
  • Diffusion Tensor Imaging (DTI): An MRI technique that measures the movement of water molecules in brain tissue, providing information about brain structure and connectivity.

References

  1. http://clinicaltrials.eu/trial/study-on-lithium-sulphate-to-prevent-cognitive-impairment-in-children-after-brain-tumor-radiotherapy/