NCT06229977CompletedPhase 2
A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
A Randomized Controlled Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 19 Jan 2024
- Start date
- 17 May 2023
- Primary completion date
- 17 Jul 2025
- Lead sponsor
- Rodrigo Machado-Vieira, MD, PhD, MSc
- Diseases
- Bipolar disorder
- NCT number
- NCT06229977
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 34
- From 17 May 2023 to the primary completion date, 17 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination
- unstable medical conditions
Lab values
- clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available
Other
- Cannabis misuse according to clinical judgement
- acute high suicidal risk
- in a manic episode
- pregnant or nursing women
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.