Abstract
Lithium is a widely used and effective treatment for individuals with psycho-neurological disorders, and it exhibits protective and regenerative properties in multiple brain injury animal models, but the clinical experience in young children is limited due to potential toxicity. As an interim analysis, this paper reports the safety/tolerability profiles of low-dose lithium treatment in children with intellectual disability (ID) and its possible beneficial effects. In a randomized, single-center clinical trial, 124 children with ID were given either oral lithium carbonate 6 mg/kg twice per day or the same dose of calcium carbonate as a placebo (n = 62/group) for 3 months. The safety of low-dose lithium treatment in children, and all the adverse events were monitored. The effects of low-dose lithium on cognition was evaluated by intelligence quotient (IQ), adaptive capacity was assessed by the Infant-Junior Middle School Students Social-Life Abilities Scale (IJMSSSLAS), and overall performance was evaluated according to the Clinical Global Impression-Improvement (CGI-I) scale. After 3 months of lithium treatment, 13/61 children (21.3%) presented with mild side effects, including 4 (6.6%) with gastrointestinal symptoms, 4 (6.6%) with neurological symptoms, 2 (3.3%) with polyuria, and 3 (4.9%) with other symptoms—one with hyperhidrosis, one with alopecia, and one with drooling. Four children in the lithium group had elevated blood thyroid stimulating hormone, which normalized spontaneously after lithium discontinuation. Both IQ and IJMSSSAS scores increased following 3 months of lithium treatment (F = 11.03, p = 0.002 and F = 7.80, p = 0.007, respectively), but such increases were not seen in the placebo group. CGI-I scores in the lithium group were 1.25 points lower (better) than in the placebo group (F = 82.66, p < 0.001) after 3 months of treatment. In summary, lithium treatment for 3 months had only mild and reversible side effects and had positive effects on cognition and overall performance in children with ID.Clinical Trial Registration: Chinese Clinical Trial Registry, ChiCTR-IPR-15007518.
Highlights
Lithium has been used for decades to treat bipolar disorder, protecting against both depression and mania (Baldessarini et al, 2018)
This paper reports the safety/tolerability profiles of lowdose lithium treatment in children with intellectual disability (ID) and its possible beneficial effects
The lithium and the placebo groups were matched for age, gender, intelligence quotient (IQ) score, IJMSSLAS score, and Clinical Global ImpressionImprovement (CGI-I) score (Table 1)
Summary
Lithium has been used for decades to treat bipolar disorder, protecting against both depression and mania (Baldessarini et al, 2018). A double-blind, placebo-controlled study in a pediatric bipolar disorder study showed that lithium was generally well tolerated and that the adverse effects were acceptable for most participants (Findling et al, 2015). A clinical study with fragile X syndrome showed that both children and young adults could benefit from lithium treatment and that the side effects were well tolerated (Berry-Kravis et al, 2008). There are indications that lithium might be a treatment option for children with mood disorders in general and bipolar disorder in particular, as well as for intellectual disorders (Campbell et al, 1995; Berry-Kravis et al, 2008; McKnight et al, 2012; Aprahamian et al, 2014; Liu and Smith, 2014; Siegel et al, 2014)
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