NCT06229977

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-17
• Primary completion: 2025-07-17
• Completion: 2025-07-17
• First posted: 2024-01-29
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study