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

CompletedPhase 2

Sponsor: Rodrigo Machado-Vieira, MD, PhD, MSc

Conditions: Bipolar Depression

Interventions: Palmitoylethanolamide (PEA), Placebo, Treatment as Usual (TAU)

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Houston, Texas, United States