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PEA plus Treatment as Usual (TAU) for Depression, Bipolar Disorder

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks follow up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with Bipolar Disorder and have a high depression score.
Select...
I am currently taking an FDA-approved mood stabilizer, with or without an antidepressant.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depression as assessed by the Hamilton Depression rating Scale (HAM-D)
Secondary outcome measures
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
~3620

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,910 Total Patients Enrolled
Baszucki Brain Research FundOTHER
6 Previous Clinical Trials
265 Total Patients Enrolled
Rodrigo Machado-Vieira, M.D, Ph.D., M.ScPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of PEA and Treatment as Usual (TAU) received official approval from the FDA?

"Based on our assessment, the safety of PEA plus Treatment as Usual (TAU) is rated at 2. This score reflects that while there is some existing data supporting its safety, no evidence has been found yet to support its efficacy in this Phase 2 trial."

Answered by AI

Who is eligible to participate in this clinical trial?

"To be considered eligible for this clinical trial, individuals must have a diagnosis of depression or bipolar disorder and fall within the age range of 18 to 70. Approximately 50 participants will be accepted into the study."

Answered by AI

Can minors under the age of 18 participate in this particular medical study?

"As outlined in the trial's eligibility criteria, individuals aged 18 to 70 years are eligible for participation."

Answered by AI

What is the current number of individuals enrolled in this clinical trial?

"Indeed, according to the information available on clinicaltrials.gov, this study is actively seeking eligible candidates. The trial was initially posted on May 17th, 2023 and recently updated on January 19th, 2024. It plans to enroll a total of 50 participants at one designated location."

Answered by AI

Are participants still being actively enrolled in this research study at the moment?

"As per the available information on clinicaltrials.gov, this trial is presently in the process of actively recruiting eligible participants. The initial posting of this study was made on May 17th, 2023 and it underwent its most recent update on January 19th, 2024."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I tried other medications that doesn't seem to help.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
Rodrigo Machado-Vieira, MD, PhD, MSc 2023. "A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229977.
All > Depression Houston > Paid Studies Pasadena
~21 spots leftby Dec 2024
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