Status:
UNKNOWN
PEA vs. Placebo for Major Depression
Lead Sponsor:
The Israeli Medical Center for Alzheimer's
Conditions:
Bipolar Depression
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Major Depression is often resistant to treatment, and all of the currently marketed anti-depressants can cause significant side effects and may precipitate mania. The aim of this proposal is to perfor...
Detailed Description
This is a multi-center, 6-week, randomized, double blind, placebo-controlled clinical trial of PEA vs. placebo in patients with unipolar or bipolar disorder who are currently in a Major Depressive Epi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06063369
Start Date
December 21 2022
End Date
December 21 2024
Last Update
October 2 2023
Active Locations (1)
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1
State University of Medicine and Pharmacy " Nicolae Testemitsanu"
Chisinau, Moldova