Anxiety & Depression Association of America

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

Purpose

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

Condition

Bipolar Depression

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental PEA plus Treatment as Usual (TAU)		Drug: Palmitoylethanolamide (PEA) Participants will receive PEA at a dose of 600mg twice daily for 6 weeks. Drug: Treatment as Usual (TAU) subjects will receive a mood stabilizer per usual care
Placebo Comparator Placebo plus Treatment as Usual (TAU)		Drug: Placebo Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks Drug: Treatment as Usual (TAU) subjects will receive a mood stabilizer per usual care

Recruiting Locations

More Details

Status: Recruiting
Sponsor: The University of Texas Health Science Center, Houston

Study Contact

Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
(713) 486-2581
Rodrigo.MachadoVieira@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.