PEA vs. Placebo for Major Depression (PEA-01)
Bipolar Depression, Major Depressive Disorder
About this trial
This is an interventional diagnostic trial for Bipolar Depression
Eligibility Criteria
Inclusion Criteria: Meet DSM V criteria for a Major Depressive Episode, with or without a diagnosis of Bipolar I or Bipolar II disorder. Between 18-65 years of age, male or female subjects of any race. 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. Have a MADRS above 20 and an YMRS < 12. Inpatients or outpatients at the discretion of the investigator. 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: Diagnosis of schizophrenia or schizoaffective disorder Women of child-bearing potential who do not practice contraception. Women who are pregnant or breast-feeding. Psychotic symptoms during the 2 weeks preceding the baseline day. Failure of three or more antidepressant treatment trials. 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). Has a clinically significant abnormal 12-lead electrocardiogram (ECG) at the Screening Visit, as determined by the Investigator. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others. Patients with a current DSM-V substance or alcohol dependence. Concurrent delirium, mental retardation, drug-induced psychosis.
Sites / Locations
- State University of Medicine and Pharmacy " Nicolae Testemitsanu"Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Palmitoylethanolamide 1200 mg
Matching placebo
Dose: PEA 1200 mg given in 300 mg capsules (2 capsules twice daily) Route of administration: oral Duration and frequency: study medication will be provided to patients in bottles every two weeks for the duration of the study (three dispensations). Formulation: PEA Dosing scheme: Patients will be instructed to take two capsules twice daily for the 42 days of the study.
2 capsules twice daily identical to study arm. Route of administration: oral Duration and frequency: pills will be provided to patients in bottles every two weeks for the duration of the study (three dispensations). Formulation: placebo in identical capsules. Dosing scheme: Patients will be instructed to take two capsules twice daily for the 42 days of the study.