Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04811404
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Martin Lan, New York State Psychiatric Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This pilot study will ask whether omega three fatty acids have an antidepressant effect in bipolar depression by decreasing brain inflammation.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Ethyl Eicosapentaenoic Acid Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : January 19, 2022
Estimated Study Completion Date : January 19, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Ethyl eicosapentaenoic acid
Ethyl eicosapentaenoic acid will be given at 1G by mouth twice per day
 Drug: Ethyl Eicosapentaenoic Acid
Treatment will be for six weeks
Other Name: Ethyl EPA; icosapent ethyl


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Montgomery Asberg Rating Scale [ Time Frame: Six weeks ]
    Minimum value of 0, maximum value of 60; Greater score reflects greater depression severity


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to provide informed consent
  2. Diagnosis of of bipolar I or bipolar 2 disorder and currently meets criteria for a major depressive episode
  3. Depression of sufficient severity to score at least 16 on the first 17 items of the Hamilton Depression Rating Scale including the atypical depression items addendum at the time of recruitment
  4. Age range 18-60
  5. Females of child-bearing potential must be willing to use an acceptable method of birth control throughout the study. These include abstinence, birth control pill, male condom, IUD, depo-provera, Norplant male sterilization, female sterilization

  6. Not taking more than two psychotropic medications at time of recruitment to avoid polypharmacy. Participants will not have changed the dose of the medication for at least 8 weeks before enrollment.

    Only participants with bipolar 2 disorder diagnosis may be off psychotropic medications at time of enrollment. In that case, they must not have stopped any medications within 8 weeks of enrollment.

    Participants can be taking diphenhydramine but no benzodiazepines or other hypnotics as needed at time of enrollment.

  7. Genotyping as a medium or high TSPO binding type

Exclusion Criteria:

  1. Diagnosis of any other major psychiatric disorders such as lifetime schizophrenia, schizoaffective disorder, current psychotic features of bipolar disorder, or recent moderate substance use disorder (within 4 months of recruitment); IV drug use. Meets DSMV criteria for a manic episode, or Young Mania Rating Scale score >12, at the time of screening.
  2. Previous failed trial or intolerable side effects of ethyl EPA or any other form of omega 3 fatty acids
  3. A first-degree family history of schizophrenia if the participant is less than 33 years old.
  4. Significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease. Any disorders with inflammation, malignancy, autoimmune or infectious etiology. Systemic blood pressure >140 or diastolic blood pressure >100. Hemoglobin <11 in females or <13 in males.
  5. Actively suicidal, as defined by expressing ideation with a plan or intent for suicide or develops suicidal ideation that requires immediate medical or treatment intervention.
  6. Pregnancy, abortion or miscarriage in the two months prior to enrollment or plans to conceive during the course of the study participation
  7. Lactating Women
  8. ECT within the last 6 months
  9. Participants who endorse a history of prior head trauma and score 1.5 standard deviations below the mean on Trailmaking A & B test
  10. Metal implants, pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body

  11. Current, past or anticipated exposure to radiation, including

    1. Having been badged for radiation exposure in the workplace
    2. Participation in nuclear medicine protocols in the last year* *Participants will be eligible, however, if the injected dose and dosimetry of the radiotracer are known and the cumulative annual exposure of the previous studies and this study is lower than the annual limit for research participants defined by FDA (21 CFR 361.1)
  12. History of claustrophobia that would prevent the participation in neuroimaging

  13. Weight >350 lbs or inability to fit into the MRI scanner**

    ** If there are doubts that the MRI scanner can accommodate the physical dimensions of the participant, the participant's circumference may be measured to determine if it is less than the MR scanner limit of 55 cm. The participant may also be brought to the MRI Center and the MRI technologist will assess whether the participant will be able to fit into the MRI scanner. Metal screening and urine pregnancy testing will be done in this circumstance before the participant enters the MRI area.

  14. Current anticoagulant or anti-platelet treatment including aspirin if needed daily
  15. Risks of delay to treatment of known efficacy (up to 9 weeks) are too great for the participant. Risks to consider include A) Severity of presenting symptoms B) History of symptom fluctuations or deterioration C) Psychosocial conditions that make delay to treatment unreasonable
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811404


Contacts
Layout table for location contacts
Contact: Martin Lan, MD 646 774 7610 martin.lan@nyspi.columbia.edu

Locations
Layout table for location information
United States, New York
New York State Psychiatric Institute/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Martin Lan, MD PHD    646-774-7610    martin.lan@NYSPI.COLUMBIA.EDU   
Sponsors and Collaborators
New York State Psychiatric Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Martin Lan, Assistant Professor of Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT04811404    
Other Study ID Numbers: 8044
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
 Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Lipid Regulating Agents