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COMPLETED
NCT06229977
PHASE2

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

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

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

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2023-05-17

Completion Date

2025-07-17

Last Updated

2026-08-13

Healthy Volunteers

No

Interventions

DRUG

Palmitoylethanolamide (PEA)

Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.

DRUG

Placebo

Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks

DRUG

Treatment as Usual (TAU)

subjects will receive a mood stabilizer per usual care

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States