A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
NCT ID: NCT06229977
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2023-05-17
2025-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PEA plus Treatment as Usual (TAU)
Palmitoylethanolamide (PEA)
Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.
Treatment as Usual (TAU)
subjects will receive a mood stabilizer per usual care
Placebo plus Treatment as Usual (TAU)
Placebo
Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks
Treatment as Usual (TAU)
subjects will receive a mood stabilizer per usual care
Interventions
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Palmitoylethanolamide (PEA)
Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.
Placebo
Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks
Treatment as Usual (TAU)
subjects will receive a mood stabilizer per usual care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Baszucki Brain Research Fund
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Rodrigo Machado-Vieira, MD, PhD, MSc
Professor
Principal Investigators
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Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-21-0989
Identifier Type: -
Identifier Source: org_study_id
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