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
Trial Summary
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
Research Team
RM
Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
Principal Investigator
The University of Texas Health Science Center, Houston
Eligibility Criteria
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
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Treatment Details
Interventions
- Palmitoylethanolamide
Trial OverviewThe 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.
Participant Groups
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
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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+
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