Efficacy and safety of palmitoylethanolamide as an adjunctive treatment for acute mania: A randomized, double-blind, placebo-controlled trial.

Aim: Palmitoylethanolamide is an endogenous fatty acid amide with neuroprotective and anti-inflammatory actions. We performed a randomized, double-blind, placebo-controlled clinical trial to investigate the efficacy and safety of palmitoylethanolamide combination therapy in acute mania.

Methods: Patients in the acute phase of mania were assigned into two parallel groups given either lithium (blood level of 0.