Palmitoylethanolamide for Bipolar Depression

Overseen By Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Mood stabilizers

Disqualifiers: Cannabis misuse, Substance use disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Palmitoylethanolamide (PEA) can reduce depression symptoms in individuals with Bipolar Disorder. Researchers aim to determine if PEA improves mood and how it interacts with the body's natural mood-related chemicals. The trial includes two groups: one taking PEA with their usual treatment and another taking a placebo (a non-active substance) with their usual treatment. It seeks participants diagnosed with Bipolar Disorder who are currently stable on at least one mood stabilizer. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you must be on at least one FDA-approved mood stabilizer, with or without an antidepressant, to participate.

Is there any evidence suggesting that Palmitoylethanolamide is likely to be safe for humans?

Research has shown that palmitoylethanolamide (PEA) is generally safe for use. Many studies have examined PEA as a safe supplement for reducing inflammation. Specifically, 47 studies tested PEA and found it safe for humans.

One study found that PEA can help manage manic symptoms and improve overall health without causing serious side effects. This suggests PEA could be a safe option for those considering it for bipolar depression.

Overall, current research supports PEA's safety, particularly as a supplement for reducing inflammation and stabilizing mood. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bipolar depression?

Palmitoylethanolamide (PEA) is unique because it offers a potential new approach to treating bipolar depression by targeting the body's endocannabinoid system, which is different from traditional medications like mood stabilizers and antipsychotics. Most standard treatments work by altering neurotransmitters like serotonin and dopamine, but PEA is a fatty acid amide that may help reduce inflammation and modulate pain, which could be beneficial for mood stabilization. Researchers are excited about PEA because it might provide relief with fewer side effects compared to current options, offering a promising alternative for individuals who don't respond well to existing treatments.

What evidence suggests that Palmitoylethanolamide might be an effective treatment for Bipolar Depression?

Research has shown that palmitoylethanolamide (PEA) might help alleviate depression symptoms. One study with individuals who have unipolar depression found that PEA had an antidepressant effect. PEA appears to work by increasing brain chemicals that improve mood. Animal studies also suggest it might influence mood by affecting specific brain areas involved in anxiety and depression. This trial will compare PEA plus Treatment as Usual (TAU) with a placebo plus TAU to evaluate its potential benefits for individuals with bipolar depression. Although research remains in the early stages, these findings offer hope that PEA could benefit those with bipolar depression. ^{1 5 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals with bipolar depression. Participants should be currently experiencing a depressive episode within their bipolar disorder but otherwise in stable condition.

Inclusion Criteria

Medically and neurologically healthy on the basis of medical history, physical examination

I have been diagnosed with Bipolar Disorder and have a high depression score.

I am currently taking an FDA-approved mood stabilizer, with or without an antidepressant.

Exclusion Criteria

Acute high suicidal risk

I do not have any uncontrolled health problems affecting my brain.

Cannabis misuse according to clinical judgement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PEA or placebo plus Treatment as Usual (TAU) for 6 weeks

6 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Palmitoylethanolamide

Trial Overview The study tests the effectiveness of Palmitoylethanolamide (PEA), an enzyme inhibitor, against Bipolar Depression. It compares PEA to a placebo and standard treatment options over time.

How Is the Trial Designed?

Group I: PEA plus Treatment as Usual (TAU) Experimental Treatment 2 Interventions

Group II: Placebo plus Treatment as Usual (TAU) Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Baszucki Brain Research Fund

Collaborator

Trials

8

Recruited

330+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35737597/

A randomized, double-blind, placebo-controlled trial Our findings provide preliminary evidence that palmitoylethanolamide is an effective adjunctive medication that improves manic symptoms and overall clinical ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06063369

NCT06063369 | PEA vs. Placebo for Major Depression There is one published study which shows that PEA has an antidepressant effect in unipolar depression, 58 patients were randomized to receive 1200 mg/d of PEA ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06063369/pea-vs-placebo-for-major-depression

PEA vs. Placebo for Major Depression Based on animal models, PEA increases Allo synthesis in areas of the brain thought to be involved in anxiety and depression. It may also favor ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pcn.13441

Efficacy and safety of palmitoylethanolamide as an ... Our findings provide preliminary evidence that palmitoylethanolamide is an effective adjunctive medication that improves manic symptoms and overall clinical ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032718315994

Role of palmitoylethanolamide (PEA) in depression ... PEA has shown antidepressant-like effects in animal models of depression. PEA induced rapid antidepressant effects as add-on to citalopram in MDD patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12189779/

Palmitoylethanolamide: A Multifunctional Molecule for ... PEA, and particularly its umPEA, has demonstrated significant potential as a safe and effective anti-inflammatory agent with broad applications ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666354624002059

Palmitoylethanolamide supplementation for human health Palmitoylethanolamide (PEA) is a safe anti-neuroinflammatory dietary supplement. 47 randomized controlled trials (RCTs) so far have studied PEA in clinical ...

8. withpower.com withpower.com/trial/phase-2-depression-4-2023-d7b27

Palmitoylethanolamide for 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 ...