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

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229977
• Other study ID #: HSC-MS-21-0989
• Status: Recruiting
• Phase: Phase 2
• Start date: May 17, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
• Phone: (713) 486-2581
• Email: Rodrigo.MachadoVieira[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Palmitoylethanolamide (PEA)
Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.
• Placebo
Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks
• Treatment as Usual (TAU)
subjects will receive a mood stabilizer per usual care

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Baszucki Brain Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of participants that show a remission of depressive symptoms as assessed by the HAM-D scale.	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)
Secondary	Percentage of participants that show a response as assessed by the HAM-D scale	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)
Secondary	Number of participants that show early improvement as defined by >20% improvement in HAM-D depression score	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
Secondary	Change in depression as assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)	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