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

January 19, 2024 updated by: Rodrigo Machado-Vieira, MD, PhD, MSc, The University of Texas Health Science Center, Houston

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Treatment as Usual (TAU)
subjects will receive a mood stabilizer per usual care
Drug: Placebo
Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression as assessed by the Hamilton Depression rating Scale (HAM-D)
Time Frame: Baseline, 6 weeks follow up
This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome
Baseline, 6 weeks follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants that show a remission of depressive symptoms as assessed by the HAM-D scale.
Time Frame: from baseline to end of study (6 week follow up)
Remission of depressive symptoms are defined by a score of ≤7 on the HAM-D. This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome
from baseline to end of study (6 week follow up)
Percentage of participants that show a response as assessed by the HAM-D scale
Time Frame: from baseline to end of study (6 week follow up)
Response rate is defined by ≥ 50 % reduction in depression score(HAM-D). This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome
from baseline to end of study (6 week follow up)
Number of participants that show early improvement as defined by >20% improvement in HAM-D depression score
Time Frame: From baseline to week 2 visit
This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome
From baseline to week 2 visit
Change in depression as assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)
Time Frame: Baseline, 6 weeks follow up
This is a 10 item questionnaire and each is scored from 0 -6 for a maximum score of 60, higher score indicating worse outcome
Baseline, 6 weeks follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Baszucki Brain Research Fund

Investigators

  • Principal Investigator: Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-21-0989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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