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

Primary Purpose

Bipolar Disorder

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ethyl Eicosapentaenoic Acid
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bipolar Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute/Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ethyl eicosapentaenoic acid

Arm Description

Ethyl eicosapentaenoic acid will be given at 1G by mouth twice per day

Outcomes

Primary Outcome Measures

Montgomery Asberg Rating Scale
Minimum value of 0, maximum value of 60; Greater score reflects greater depression severity

Secondary Outcome Measures

Full Information

First Posted
March 19, 2021
Last Updated
October 12, 2022
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04811404
Brief Title
A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid
Official Title
A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Reassessment of rationale for study
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study will ask whether omega three fatty acids have an antidepressant effect in bipolar depression by decreasing brain inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethyl eicosapentaenoic acid
Arm Type
Experimental
Arm Description
Ethyl eicosapentaenoic acid will be given at 1G by mouth twice per day
Intervention Type
Drug
Intervention Name(s)
Ethyl Eicosapentaenoic Acid
Other Intervention Name(s)
Ethyl EPA; icosapent ethyl
Intervention Description
Treatment will be for six weeks
Primary Outcome Measure Information:
Title
Montgomery Asberg Rating Scale
Description
Minimum value of 0, maximum value of 60; Greater score reflects greater depression severity
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to provide informed consent Diagnosis of of bipolar I or bipolar 2 disorder and currently meets criteria for a major depressive episode 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 Age range 18-60 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 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. Genotyping as a medium or high TSPO binding type Exclusion Criteria: 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. Previous failed trial or intolerable side effects of ethyl EPA or any other form of omega 3 fatty acids A first-degree family history of schizophrenia if the participant is less than 33 years old. 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. 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. Pregnancy, abortion or miscarriage in the two months prior to enrollment or plans to conceive during the course of the study participation Lactating Women ECT within the last 6 months Participants who endorse a history of prior head trauma and score 1.5 standard deviations below the mean on Trailmaking A & B test Metal implants, pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body Current, past or anticipated exposure to radiation, including Having been badged for radiation exposure in the workplace 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) History of claustrophobia that would prevent the participation in neuroimaging 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. Current anticoagulant or anti-platelet treatment including aspirin if needed daily 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
Facility Information:
Facility Name
New York State Psychiatric Institute/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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