50 Participants Needed

Palmitoylethanolamide for Bipolar Depression

AH
RM
Overseen ByRodrigo 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
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

RM

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
See 5 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PEA plus Treatment as Usual (TAU)Experimental Treatment2 Interventions
Group II: Placebo plus Treatment as Usual (TAU)Placebo Group2 Interventions

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
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