| Eligibility |
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
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