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

NCT06229977 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HSC-MS-21-0989
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cytokine levels

Outcome Measures

Primary Outcomes (1)

• Change in Depression as Assessed by the Hamilton Depression Rating Scale (HAM-D)

  The Hamilton Depression Rating Scale measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity. The change in score will be reported. The change in score will be reported as the \[(Score at 6 weeks follow up) - (Score at Baseline)\] - A negative value indicates improvement of depression severity.

  Baseline, 6 weeks follow up

Secondary Outcomes (4)

• Number of Participants That Show a Remission of Depressive Symptoms as Assessed by the HAM-D Scale

  from baseline to end of study (6 week follow up)

• Number of Participants That Show a Response as Assessed by the HAM-D Scale

  from baseline to end of study (6 week follow up)

• Change in Depression as Assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)

  Baseline, 6 weeks follow up

• Time to Response - HAM-D (≥50% Reduction From Baseline)

  Baseline To Week 6

Study Arms (2)

PEA plus Treatment as Usual (TAU)

EXPERIMENTAL

Drug: Palmitoylethanolamide (PEA); Drug: Treatment as Usual (TAU)

Placebo plus Treatment as Usual (TAU)

PLACEBO COMPARATOR

Drug: Placebo; Drug: Treatment as Usual (TAU)

Interventions

Palmitoylethanolamide (PEA) DRUG

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

PEA plus Treatment as Usual (TAU)

Placebo DRUG

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

Placebo plus Treatment as Usual (TAU)

Treatment as Usual (TAU) DRUG

subjects will receive a mood stabilizer per usual care

PEA plus Treatment as Usual (TAU); Placebo plus Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D
• currently in use of at least one FDA approved mood stabilizer with or without antidepressant
• medically and neurologically healthy on the basis of medical history, physical examination

You may not qualify if:

• Cannabis misuse according to clinical judgement
• unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects
• active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder)
• acute high suicidal risk
• in a manic episode
• current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination
• pregnant or nursing women
• unstable medical conditions
• clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available

Sponsors & Collaborators

• Rodrigo Machado-Vieira, MD, PhD, MSc: lead
• Milken Institute: collaborator
• Baszucki Brain Research Fund: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

palmidrol; Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Rodrigo Machado-Vieira
• Organization: The University of Texas Health Science Center at Houston

Rodrigo.MachadoVieira@uth.tmc.edu

713-500-1832

Study Officials

• Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: May 17, 2023
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: August 13, 2026
• Results First Posted: August 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)