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A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT06229977•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

May 17, 2023

Primary Completion Date

July 17, 2025

Completion Date

July 17, 2025

Last Updated

October 2, 2025

Enrollment

ACTUAL participants

Conditions

Bipolar Depression

Interventions

Palmitoylethanolamide (PEA)

DRUG

Placebo

DRUG

Treatment as Usual (TAU)

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGNA

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

NCT06524505

Bipolar Depression

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

HD-tDCS for Adolescent Bipolar Depression Targeting S1

Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms