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A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
Sponsor: Rodrigo Machado-Vieira, MD, PhD, MSc
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
Conditions
Interventions
Palmitoylethanolamide (PEA)
Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.
Placebo
Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks
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