NCT06229977

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

January 19, 2024

Last Update Submit

September 28, 2025

Conditions

Bipolar Depression

Keywords

cytokine levels

Outcome Measures

Primary Outcomes (1)

  • Change in depression as assessed by the Hamilton Depression rating Scale (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

    Baseline, 6 weeks follow up

Secondary Outcomes (4)

  • Percentage of participants that show a remission of depressive symptoms as assessed by the HAM-D scale.

    from baseline to end of study (6 week follow up)

  • Percentage of participants that show a response as assessed by the HAM-D scale

    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

    From baseline to week 2 visit

  • Change in depression as assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)

    Baseline, 6 weeks follow up

Study Arms (2)

PEA plus Treatment as Usual (TAU)

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

Placebo plus Treatment as Usual (TAU)

PLACEBO COMPARATOR
Drug: PlaceboDrug: Treatment as Usual (TAU)

Interventions

Palmitoylethanolamide (PEA)DRUG

Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.

PEA plus Treatment as Usual (TAU)
PlaceboDRUG

Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks

Placebo plus Treatment as Usual (TAU)
Treatment as Usual (TAU)DRUG

subjects will receive a mood stabilizer per usual care

PEA plus Treatment as Usual (TAU)Placebo plus Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

palmidrolTherapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 29, 2024

Study Start

May 17, 2023

Primary Completion

July 17, 2025

Study Completion

July 17, 2025

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)