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Palmitoylethanolamide for Bipolar Depression

Phase 2
Recruiting
Led By Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks follow up

Summary

This trial aims to determine if a medication called PEA can effectively treat bipolar depression. The study will also look at how the body's natural cannabinoids and cytokine levels are related to the response to antidepress

Who is the study for?
This trial is for individuals with bipolar depression. Participants should be currently experiencing a depressive episode within their bipolar disorder but otherwise in stable condition.
What is being tested?
The study tests the effectiveness of Palmitoylethanolamide (PEA), an enzyme inhibitor, against Bipolar Depression. It compares PEA to a placebo and standard treatment options over time.
What are the potential side effects?
While specific side effects are not listed, PEA could potentially cause mild stomach discomfort or allergic reactions. Standard treatments and placebos typically have minimal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Bipolar Disorder and have a high depression score.
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I am currently taking an FDA-approved mood stabilizer, with or without an antidepressant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any uncontrolled health problems affecting my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in depression as assessed by the Hamilton Depression rating Scale (HAM-D)
Secondary study objectives
Change in depression as assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)
Number of participants that show early improvement as defined by >20% improvement in HAM-D depression score
Percentage of participants that show a remission of depressive symptoms as assessed by the HAM-D scale.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PEA plus Treatment as Usual (TAU)Experimental Treatment2 Interventions
Group II: Placebo plus Treatment as Usual (TAU)Placebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment as Usual (TAU)
2016
Completed Phase 4
~3870

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,975 Total Patients Enrolled
Baszucki Brain Research FundOTHER
7 Previous Clinical Trials
283 Total Patients Enrolled
Rodrigo Machado-Vieira, M.D, Ph.D., M.ScPrincipal InvestigatorThe University of Texas Health Science Center, Houston
~3 spots leftby Dec 2024
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