Please select the eligibility criteria that correspond to the clinical trial below.
Title: Role of Omega-3 Fish Oil Fatty Acids on Depression Among HIV-seropositive Pregnant Pregnant Women in Nairobi: A Randomized Double-blind Controlled Trial
Brief Summary: Fish oil omega-3 supplements provide essential nutrients for brain health and functioning. These nutrients have been proven to be effective in reducing depressive symptoms. They have also been found to be effective and well tolerated in reducing the bad fat accumulation among patients infected with human immunodeficiency virus (HIV)and are using highly active antiretroviral treatment. The role of this nutritional supplement in combating depression among pregnant women who are living with HIV infection has however not been established. Yet, currently, more than 2 million pregnant women are estimated to be living with HIV infection globally. In Kenya, about 9.0% of pregnant women are HIV-seropositive.

In this study, it is hypothesized that there is no difference in the levels of depressive symptoms among HIV infected pregnant women who are taking omega-3 fish oil supplements and those taking a placebo.

The study will therefore seek to ascertain that taking omega-3 fish oil nutritional supplement has a significant positive effect on depressive symptoms among HIV infected pregnant women, compared to a placebo.


Options:
A: Inclusion Criteria:

* All pregnant HIV seropositive women with known CD4 cell count less than 500
* Pregnant women who are in their 2nd trimester of pregnancy (Week 13-27).
* Normal nutritional status pregnancy with mid-upper arm circumference (MUAC of 22 cm - 33 cm)at entry into the study;
* Beck Depression Inventory Second Edition (BDI-II) Scale scores at entry into the study of 14 or more;
* Pregnant HIV positive women who will give consent to participate in the study

Exclusion Criteria:

* Underweight with MUAC less than 22 cm and overweight with MUAC more than 33 cm at entry into the study;
* Pregnant women taking antidepressant medications;
* Those on anti-clotting medication (those with liver disease, varicose veins, peptic ulcers); or Vitamin K supplement. Omega-3 supplements may increase their effects;
* Those on diabetic medication since Omega-3 may increase their blood sugar.
* Incomplete depression screening form (more than 5 items unanswered)
* Those whose BDI-II screening scores are less than 14;
* Those women currently taking omega-3 nutritional supplement
* Pregnant HIV-seropositive women without consent to participate in the study.
B: Inclusion Criteria:

1. Males or females ages 25-60. Must be able to read and understand English.
2. Currently meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for a major depressive episode. (History of either unipolar major depression (depressive episodes only) or bipolar I disorder (history of manias and depressions) or bipolar II disorder (hypomanias and depressions), current episode depressed acceptable).
3. Must meet criteria for "treatment resistant" depression defined by failure to respond to, or intolerance of, at least 2 treatment trials (antidepressants or ECT) during the current episode.
4. All subjects will be fully ambulatory and in good medical health.
5. Are required to either be antidepressant free for 2 weeks prior to study entry (4 weeks for fluoxetine secondary to long half-life) or be on a fixed psychotropic medication regimen for at least 4 weeks. Subjects and their primary care providers must agree to continue their status (i.e. without antidepressant or on a fixed regimen) until the 12-week assessment is complete.
6. Pre-menopausal female subjects must not be pregnant and must be willing to use adequate contraception during the study period.

Exclusion Criteria:

1. Current or history of psychotic symptoms.
2. Active suicidal ideation (defined as a score of ≥3 on Hamilton Depression Rating Scale (HDRS) suicide item).
3. Prior use of a TNF-alpha antagonist (i.e. etanercept, infliximab, adalimumab) and use of any other immunosuppressant agent (i.e. systemic corticosteroids or anti-proliferative agents such as methotrexate) within one year of study entry.
4. Current use of aspirin, non-steroidal anti-inflammatory agents (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors during the study. Acetaminophen will be allowed.
5. History of any of the following conditions: Congestive heart failure, abnormal electrocardiogram, malignancy, schizophrenia, neurological disease, auto-immune condition (e.g. rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, lupus), chronic infection (e.g. human immunodeficiency virus, hepatitis B or C), and hematologic, renal or hepatic abnormality.
6. Subjects will be excluded for a positive anti-double stranded DNA antibody test.
C: Inclusion Criteria:

* Diagnosis of relapsing-remitting MS
* Diagnosis of depressive disorder
* Score between 11 and 30 on the Montgomery-Asberg Depression Rating Scale (MADRS)
* Score of 25 or greater on the Mini-Mental State Examination (MMSE)
* Currently taking antidepressant medication for at least 3 months prior to study entry

Exclusion Criteria:

* Currently taking fatty acid supplements
* Consume more than 6 oz of fish per week within 1 month prior to study entry
* Severe depression
* Suicidal thoughts
* Other psychological disorders
* Currently taking more than two types of antidepressants
* Any serious medical condition that would interfere with the study
* Worsening of MS symptoms or corticosteroid treatment within 1 month prior to study entry
* Current enrollment in another fish oil study
* Pregnancy
D: Inclusion Criteria:

* Eligible participants will be adult patients with chronic HCV, assessed by hepatologists and then referred for IFN-α therapy and have capacity and willingness to give written informed consent

Exclusion Criteria:

* Patients will be excluded if they have major depressive episode at assessment
* Any history of pre-existing psychotic disorders (e.g. schizophrenia or bipolar disorder)
* Alcohol or drug dependence within one year before entry into the study
* Seizure disorders and evidence of any unstable substantial coexisting medical conditions (e.g. cardiovascular, endocrine, haematological, renal, or neurological diseases)

Answer: A