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

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

May 17, 2023

Primary Completion Date

July 17, 2025

Study Completion Date

July 17, 2025

Conditions
Bipolar Depression
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

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

Baszucki Brain Research Fund

OTHER

lead

The University of Texas Health Science Center, Houston

OTHER

NCT06229977 - A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression | Biotech Hunter | Biotech Hunter