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

ArmDescriptionAssigned 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

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
(713) 486-2581
Rodrigo.MachadoVieira@uth.tmc.edu

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