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

Phase 2

Recruiting

• Conditions: Bipolar Depression
• Interventions: Drug: Palmitoylethanolamide (PEA); Drug: Placebo; Drug: Treatment as Usual (TAU)

• Registration Number: NCT06229977
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-17
• Status Verified: 2024-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEA plus Treatment as Usual (TAU)	Palmitoylethanolamide (PEA)	-
PEA plus Treatment as Usual (TAU)	Treatment as Usual (TAU)	-
Placebo plus Treatment as Usual (TAU)	Placebo	-
Placebo plus Treatment as Usual (TAU)	Treatment as Usual (TAU)	-

Primary Outcome Measures

Name	Time	Method
Change in depression as assessed by the Hamilton Depression rating Scale (HAM-D)	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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants that show a response as assessed by the HAM-D scale	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
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)	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
Number of participants that show early improvement as defined by >20% improvement in HAM-D depression score	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
Change in depression as assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)	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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States