Influenza Challenge in Mood Disorders
MAJOR DEPRESSIVE DISORDER
About this trial
This is an interventional basic science trial for MAJOR DEPRESSIVE DISORDER
Eligibility Criteria
Inclusion Criteria:
Major Depressive Disorder Patient Group - Currently Depressed: Subjects will have met Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-V) criteria for primary MDD in a current major depressive episode and current Hamilton Depression Rating Scale (HAM-D) or Montgomery Asberg Depression Rating Scale (MADRS) score in the mild-to-severely depressed range and will have been deemed to be medically stable by a physician listed on this protocol. Subjects who do not wish to receive treatment with psychotropic medication in the future and have not taken psychotropic medication for at least 3 weeks will be included in the study.
Healthy Comparison Group: Subjects will be selected who have not met criteria for any Axis I psychiatric disorder, have no known first-degree relatives with mood or anxiety disorders, and have a current score on the HAM-D or MADRS in the non-depressed range.
Exclusion Criteria:
Inability to provide informed consent, pregnant or nursing women, known hypersensitivity to vaccines, age of onset of MDD > 40 years, metal implants or other factors that would preclude MRI scanning, serious risk of suicide, delusions or hallucinations, medical or neurological illnesses (such as diabetes, autoimmune disorders or inflammatory bowel disease) that affect brain structure, function or immune measurements, previous head injury with loss of consciousness, abuse of drugs or alcohol within the previous year or a lifetime history of substance dependence, treatment with medications that impact immune function (e.g. prednisone), HIV or other chronic infection, a recent acute illness (e.g. influenza), receipt of a vaccine within 3 months of commencing the study. Subjects whose first major depressive episodes arose temporally after other major medical or psychiatric conditions will also be excluded, since their functional imaging results generally differ from those reported in primary MDD.
Subjects will be asked not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48 hr. before each study day. The use of oral contraceptives and menstrual phase or status are not exclusion criteria but this information will be recorded. The same exclusion criteria apply to healthy controls with the added criterion that first-degree relatives should be free of major psychiatric illness as assessed with the Family Interview for Genetic Studies (FIGS).
Sites / Locations
- Laureate Institute for Brian Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
VACCINE MDD
PLACEBO MDD
VACCINE HC
PLACEBO HC
SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.
SALINE (0.5ML) DELIVERED I.M.
SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.
SALINE (0.5ML) DELIVERED I.M.