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Completed

NCT Number: NCT06229977

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

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

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Key information

Conditions

Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Palmitoylethanolamide (PEA)

Drug

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

Placebo

Drug

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

Treatment as Usual (TAU)

Drug

subjects will receive a mood stabilizer per usual care

Primary outcomes

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

    Time frame: Baseline, 6 weeks follow up

    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.

Secondary outcomes

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

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

    Remission of depressive symptoms is defined by a HAM-D score of ≤7. The Hamilton Depression Rating Scale (HAM-D) measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity

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

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

    Response rate is defined by ≥ 50 % reduction in HAM-D Score from baseline. The Hamilton Depression Rating Scale (HAM-D) measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity

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

    Time frame: Baseline, 6 weeks follow up

    The Montgomery Äsberg Depression Rating Scale measures severity in depression. The total score ranges from 0 to 60, a higher score indicating greater depression. 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.

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

    Time frame: Baseline To Week 6

    Time to first study visit at which a participant achieved ≥50% reduction from baseline HAM-D total score. The Hamilton Depression Rating Scale (HAM-D) measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity

Sponsors and collaborators

Lead sponsor

Rodrigo Machado-Vieira, MD, PhD, MSc

Other

Collaborators

  • Baszucki Brain Research Fund
  • Milken Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2024
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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