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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

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

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.