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

NCT04811404 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 8044
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Rating Scale

  Minimum value of 0, maximum value of 60; Greater score reflects greater depression severity

  Six weeks

Study Arms (1)

Ethyl eicosapentaenoic acid

EXPERIMENTAL

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

Drug: Ethyl Eicosapentaenoic Acid

Interventions

Ethyl Eicosapentaenoic Acid DRUG

Treatment will be for six weeks

Also known as: Ethyl EPA; icosapent ethyl

Ethyl eicosapentaenoic acid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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\*\*

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute/Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

eicosapentaenoic acid ethyl ester; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: March 19, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)