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The primary aim of the study is to determine the effect of Li+ at 12 weeks, compared to placebo, on the social communication deficit in patients with Phelan-McDermid Syndrome. The Secondary Objectives are: To determine the effects of Li+ on all cardinal and key signs in patients suffering from Phelan-McDemid Syndrome for 12 weeks. Evaluate the Tolerability of Li+ for 12 weeks in children suffering from PMS for a year. Lithium carbonate capsules are made from the raw material for pharmaceutical use, according to the study's author. Every 4 days until the desired lithiaemia of 0. 4-0. 6 meq/L is achieved with progressive increase of the lithium dose administered, a lithiaemia will be performed. In the control arm, a placebo therapy is still required, as the assessment is based on hetero-evaluation.
Source link: https://clinicaltrials.gov/ct2/show/NCT04623398
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