Can a fatty acid lift bipolar depression?
NCT ID NCT06229977
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tested whether a natural compound called palmitoylethanolamide (PEA) can help reduce depression in people with bipolar disorder. 34 adults who were already taking a mood stabilizer took PEA or a placebo. Researchers measured changes in depression scores and looked at how the body's own cannabinoids and immune markers responded.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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34 people
The number who actually took part.
- Started
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May 2023
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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