Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder Patients
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, MDD, Psychiatry disorders, Psychosocial stressor, Psychosocial stress, Typhoid vaccination, Typhoid vaccine
Eligibility Criteria
Inclusion criteria:
- Has body mass index (BMI) [weight in kilograms / (height in meters x height in meters)] between 18 and 30 kg/m2
- For young healthy participants: female, 25 to 45 years of age; elderly healthy participants: female: ≥ 65 years of age & with baseline C-reactive protein (CRP) > 5 mg/mL; (partially) remitted MDD patients: female, 25 to 45 years of age
- Inclusion criteria specific for patients with MDD: -Patients with a history (within 24 months) of MDD must have a Montgomery-Asberg Depression Rating Scale (MADRS) total score < 15 and symptom remission (temporary absence of disease symptoms) relative to the acute episode must have been present for at least 3 months
Exclusion Criteria:
- Has a current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I diagnosis (other than MDD)
- Has recently experienced a psychosocial stressor within 6 months
- Has acute symptoms of suicidality (the likelihood of an individual completing suicide)
- Has a DSM-IV diagnosis of substance abuse or dependence within 6 months prior to screening evaluation
- Has been exposed to an experimental medication or experimental medical device within 90 days before screening
- Has a serology (scientific study of blood serum and other bodily fluids) positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV antibodies at screening
- Has been exposed to typhoid or typhoid vaccine within 5 years before screening
- Has been prior exposed to the Trier Social Stress Test (TSST)
- Has received electroconvulsive therapy (shock therapy) within 3 months before screening
- Has been involuntarily committed to psychiatric hospitalization
- Has donated 1 or more units (approximately 450 mL) of blood or had an acute loss of an equivalent amount of blood within 90 days prior to study medication administration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Other
Other
Other
Other
Other
Other
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Treatment AB: Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment B (typhoid vaccination) administered [Period 2]
Treatment BA: Treatment B (typhoid vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]
Treatment AC: Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment C (TSST+Placebo vaccination) administered [Period 2]
Treatment CA: Treatment C (TSST+Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]
Treatment AD:Treatment A (Placebo vaccination) administered [Period 1], after the washout period (7-14 days) Treatment D (TSST+typhoid vaccination) administered [Period 2]
Treatment DA:Treatment D (TSST+typhoid vaccination) administered [Period 1], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered [Period 2]