In short
Clinical trials are investigating Lithium Carbonate in people with bipolar disorder type II and in patients with TBR1-related neurocognitive disorder. These studies are looking at how well it works, how safe it is in the trial setting, and what outcomes it may improve, such as mood stability and adaptive behavior.
Key points
- Clinical trials of Lithium Carbonate in this data are focused on two very different patient groups. One Phase 3 study is testing it in bipolar disorder type II and comparing it with lamotrigine to see whether mood stability improves. Another small Phase 1 study is testing 24 months of treatment in patients with a proven or probably pathogenic TBR1 variant and measuring adaptive behavior. Both studies are interventional and are listed as authorised. The main outcomes are mood instability in the bipolar study and Vineland II adaptive behavior scores in the TBR1-related study. No final results are shown here.
Trials overview
Two interventional studies are investigating Lithium Carbonate in very different patient groups. One study is for people with bipolar disorder type II, and the other is for patients with a proven or probably pathogenic TBR1 variant linked to neurocognitive disorder.
Both studies are listed as authorised, which means they have approval to begin. The available data focus on study aims, patient groups, and main outcomes rather than final results.
Bipolar disorder type II study
The LiLa-Bipolar RCT is a single-blinded randomized controlled trial in people with bipolar disorder type II. It is a Phase 3 study with about 200 participants, and it plans to compare Lithium Carbonate with lamotrigine over 6 months.
The study is designed to test whether Lithium Carbonate improves mood stabilization better than lamotrigine. The brief summary also says the researchers want to see whether the main effect is antimanic, antidepressant, or preventive against relapse, which means stopping the illness from coming back.
TBR1-related neurocognitive disorder study
The ESALIT study is a pilot, multicentre, open-label study in patients with a proven pathogenic or probably pathogenic TBR1 variant. It is a Phase 1 study with 12 participants and plans to evaluate 24 months of Lithium Carbonate treatment after an observational period of 6 to 12 months.
This study is focused on adaptive behavior, which means everyday skills such as communication and daily functioning. The researchers want to see whether treatment leads to a clinical response measured by improvement in the Vineland II Adaptive Behaviour Scale at the end of the 24 months.
What the trials measure
In the bipolar disorder study, the main outcome is mood stabilization, measured by a mood instability score based on daily self-monitored mood data collected with the Monsenso system. This means the trial is looking at how much a person’s mood changes from day to day.
In the TBR1-related study, the main outcome is clinical response based on change in the Vineland II Adaptive Behaviour Scale. The study defines response as improvement at 24 months that is at least as large as the standard error of the mean at baseline, which is a statistical way to judge whether the change is meaningful.
Study design, phase, and enrollment
The bipolar disorder trial is a randomized controlled trial, which means participants are assigned to treatment groups by chance. It is single-blinded, so one side of the study does not know which treatment the participant receives.
The TBR1-related study is open-label, which means both participants and researchers know which treatment is being given. It is also multicentre, so it takes place at more than one study site.
The enrollment is very different between the two trials: about 200 participants in the bipolar disorder study and 12 participants in the TBR1-related study. This shows that the first trial is much larger, while the second is a small pilot study.
Who can participate
The bipolar disorder study is for patients with bipolar disorder type II. The TBR1-related study is for patients with a proven pathogenic or probably pathogenic TBR1 variant.
These are narrow target groups, so the studies are not open to all patients with mood or developmental problems. Each trial is built around a specific diagnosis or genetic finding, and the outcomes are matched to that group’s needs.