Testing PEA for treating Major Depression

Palmitoylethanolamide (PEA) vs Placebo for Major Depression: a Phase II Exploratory Study

This study is testing if a new treatment called PEA can help people with major depression, including those with bipolar disorder, feel better over six weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The Israeli Medical Center for Alzheimer's (Academic / other)
• Locations: 1 site (Chișinău)
• Trial ID: NCT06063369 on ClinicalTrials.gov

What this trial studies

This clinical trial is a proof-of-concept randomized controlled trial that investigates the efficacy of Palmitoylethanolamide (PEA) as a treatment for patients experiencing Major Depressive Episodes, including those with bipolar disorder. A total of 100 participants will be randomized to receive either PEA or a placebo for six weeks, with a careful tapering of any existing antidepressant or mood stabilizer medications. The study will assess various psychiatric scales and biomarkers to evaluate the treatment's impact on depression symptoms and overall mental health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 who meet the DSM V criteria for a Major Depressive Episode, with or without bipolar disorder.

Not a fit: Patients with schizophrenia, schizoaffective disorder, or those who have failed three or more antidepressant treatment trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel and potentially effective option for patients suffering from Major Depression with fewer side effects compared to traditional antidepressants.

How similar studies have performed: While the use of PEA in treating depression is a novel approach, similar studies targeting the modulation of neurosteroids have shown promise in related conditions.

Eligibility criteria

Inclusion Criteria:

1. Meet DSM V criteria for a Major Depressive Episode, with or without a diagnosis of Bipolar I or Bipolar II disorder.
2. Between 18-65 years of age, male or female subjects of any race.
3. Able to provide informed consent. All participant patients must have signed an informed consent document indicating they understand the purpose of the study and are willing to complying with the study procedures and restrictions.
4. Have a MADRS above 20 and an YMRS \< 12.
5. Inpatients or outpatients at the discretion of the investigator.
6. Live with a caregiver or have a relative/close friend who is in contact with them at least twice a week via phone.

Exclusion Criteria:

1. Diagnosis of schizophrenia or schizoaffective disorder
2. Women of child-bearing potential who do not practice contraception.
3. Women who are pregnant or breast-feeding.
4. Psychotic symptoms during the 2 weeks preceding the baseline day.
5. Failure of three or more antidepressant treatment trials.
6. Unstable medical disease (malignancy, poorly controlled diabetes, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning. Particular attention should be given to exclude patients with ischemic heart disease).
7. Has a clinically significant abnormal 12-lead electrocardiogram (ECG) at the Screening Visit, as determined by the Investigator.
8. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
9. Patients with a current DSM-V substance or alcohol dependence.
10. Concurrent delirium, mental retardation, drug-induced psychosis.

Where this trial is running

Chișinău

• State University of Medicine and Pharmacy " Nicolae Testemitsanu" — Chișinău, Moldova, Republic of (Recruiting)

Study contacts

• Study coordinator: Igor Nastas, Dr

Conditions Bipolar Depression; Major Depressive Disorder