A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression

Description

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

Conditions

Bipolar Depression

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Study Overview

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Study Details

Study overview

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

A Randomized Controlled Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression

A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression

Condition
Bipolar Depression
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2024-12-31