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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Jan 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Palmitoylethanolamide (PEA) to see if it can help relieve symptoms of bipolar depression. The researchers want to find out if the way this medication works is related to certain natural chemicals in the body and other factors that could affect mood. The study is currently looking for participants who are between the ages of 18 and 65 and have been diagnosed with bipolar disorder. To be eligible, individuals must be using at least one approved mood-stabilizing medication and have moderate to severe depression symptoms.

Participants in this trial will undergo a series of assessments to ensure they meet the study requirements and to monitor their health. They will receive the study medication and be closely monitored by medical professionals throughout the trial. It's important to note that those with certain health conditions, recent substance misuse, or who are pregnant or nursing cannot participate. This study aims to provide valuable information about potential new treatments for bipolar depression, and participants may contribute to important advancements in mental health care.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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