A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression

A Randomized Controlled Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression

The purpose of this study is to o evaluate the antidepressant efficacy of the PEA in Bipolar Depression and the association between antidepressant response with endogenous cannabinoids and cytokine levels

Inclusion Criteria:

• diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D
• currently in use of at least one FDA approved mood stabilizer with or without antidepressant
• medically and neurologically healthy on the basis of medical history, physical examination

Exclusion Criteria:

• Cannabis misuse according to clinical judgement
• unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects
• active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder)
• acute high suicidal risk
• in a manic episode
• current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination
• pregnant or nursing women
• unstable medical conditions
• clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available