Table of Contents
- Trials overview
- Bipolar disorder type II study
- TBR1-related neurocognitive disorder study
- What the trials measure
- Study design, phase, and enrollment
- Who can participate
Trials overview
Two interventional studies are investigating Lithium Carbonate in very different patient groups.[1][2] 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.[1][2]
Both studies are listed as authorised, which means they have approval to begin.[1][2] The available data focus on study aims, patient groups, and main outcomes rather than final results.[1][2]
Bipolar disorder type II study
The LiLa-Bipolar RCT is a single-blinded randomized controlled trial in people with bipolar disorder type II.[1] It is a Phase 3 study with about 200 participants, and it plans to compare Lithium Carbonate with lamotrigine over 6 months.[1]
The study is designed to test whether Lithium Carbonate improves mood stabilization better than lamotrigine.[1] 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.[1]
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.[2] 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.[2]
This study is focused on adaptive behavior, which means everyday skills such as communication and daily functioning.[2] 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.[2]
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.[1] This means the trial is looking at how much a person’s mood changes from day to day.[1]
In the TBR1-related study, the main outcome is clinical response based on change in the Vineland II Adaptive Behaviour Scale.[2] 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.[2]
Study design, phase, and enrollment
The bipolar disorder trial is a randomized controlled trial, which means participants are assigned to treatment groups by chance.[1] It is single-blinded, so one side of the study does not know which treatment the participant receives.[1]
The TBR1-related study is open-label, which means both participants and researchers know which treatment is being given.[2] It is also multicentre, so it takes place at more than one study site.[2]
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.[1][2] This shows that the first trial is much larger, while the second is a small pilot study.[1][2]
Who can participate
The bipolar disorder study is for patients with bipolar disorder type II.[1] The TBR1-related study is for patients with a proven pathogenic or probably pathogenic TBR1 variant.[2]
These are narrow target groups, so the studies are not open to all patients with mood or developmental problems.[1][2] Each trial is built around a specific diagnosis or genetic finding, and the outcomes are matched to that group’s needs.[1][2]
