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Lamotrigine + placebo refers to a treatment regimen used as a comparator arm in clinical research, specifically in the Phase 4 randomized withdrawal study CN138-392 conducted by Otsuka Pharmaceutical Development & Commercialization and Bristol Myers Squibb. This regimen was employed to evaluate the long-term maintenance efficacy of aripiprazole as an adjunctive therapy to lamotrigine in patients with bipolar I disorder who had recently experienced a manic or mixed episode. Lamotrigine is a small molecule anticonvulsant and mood stabilizer that primarily acts by inhibiting voltage-gated sodium channels, thereby stabilizing neuronal membranes and suppressing the presynaptic release of excitatory neurotransmitters like glutamate. In this combination, the placebo serves as a pharmacologically inactive control for the adjunctive antipsychotic component.
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