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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Enrolling
Phase 2

Conditions

Bipolar Depression

Treatments

Drug: Palmitoylethanolamide (PEA)
Drug: Placebo
Drug: Treatment as Usual (TAU)

Study type

Interventional

Funder types

Other

Identifiers

NCT06229977
HSC-MS-21-0989

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups, including a placebo group

PEA plus Treatment as Usual (TAU)
Experimental group
Treatment:
Drug: Treatment as Usual (TAU)
Drug: Palmitoylethanolamide (PEA)
Placebo plus Treatment as Usual (TAU)
Placebo Comparator group
Treatment:
Drug: Treatment as Usual (TAU)
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Abdul Haseeb; Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc

Data sourced from clinicaltrials.gov

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