Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01533285 | Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder Patients | EARLY_PHASE1 | COMPLETED | 40 | — | — | May 1, 2012 | Nov 1, 2013 | Mar 28, 2014 | 2 | Belgium |
Participants score on a scale ranging from 0 (not at all) to 4 (extremely) any of 30 statements related to their mood / energy level by circling the appropriate number.
Participants rate the way they feel on a 10 mm line separating statements along the extremes of different dimensions (eg, alert - drowsy).
Participants endorse any of 14 statements in 4 categories (Strongly Agree, Agree, Disagree, Strongly Disagree) by ticking the appropriate answer.
The MADRS is used by trained blinded site staff to rate the severity of depression. It consists of 10 items. The minimal rating is 0 (absent) and the maximal rating is 6 (most serious).
| Arm | Type | Description |
|---|---|---|
| Group 1 | OTHER | Treatment AB: Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment B (typhoid vaccination) administered \[Period 2\] |
| Group 2 | OTHER | Treatment BA: Treatment B (typhoid vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\] |
| Group 3 | OTHER | Treatment AC: Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment C (TSST+Placebo vaccination) administered \[Period 2\] |
| Group 4 | OTHER | Treatment CA: Treatment C (TSST+Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\] |
| Group 5 | OTHER | Treatment AD:Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment D (TSST+typhoid vaccination) administered \[Period 2\] |
| Group 6 | OTHER | Treatment DA:Treatment D (TSST+typhoid vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\] |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2. |
| Salmonella typhi vaccine (Typhim Vi) | BIOLOGICAL | Salmonella typhi vaccine (typhoid vaccination) in Treatment B and D; Unit = mg, number = 0.025, form = solution for intramuscularly (IM) injection, route = IM administered on Day 1 of Period 1 and Period 2. |
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) ...