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

NCT06229977 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-10-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Baszucki Brain Research Fund

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-17
Primary Completion
2025-07-17
Completion
2025-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229977 on ClinicalTrials.gov