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

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Conditions

Bipolar Depressioncytokine levels

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-05-17
Study Completion:2025-07-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06229977

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * currently in use of at least one FDA approved mood stabilizer with or without antidepressant
  3. * medically and neurologically healthy on the basis of medical history, physical examination
  1. * Cannabis misuse according to clinical judgement
  2. * unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects
  3. * active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder)
  4. * acute high suicidal risk
  5. * in a manic episode
  6. * current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination
  7. * pregnant or nursing women
  8. * unstable medical conditions
  9. * clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-17
Study Completion Date2025-07-17

Study Record Updates

Study Start Date2023-05-17
Study Completion Date2025-07-17

Terms related to this study

Keywords Provided by Researchers

  • cytokine levels

Additional Relevant MeSH Terms

  • Bipolar Depression