Major Depressive Disorder (MDD)
Conditions
Brief summary
The primary endpoint is the mean change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to Day 28 (Week 4). This will assess the short-term efficacy of the treatment.
Detailed description
The secondary endpoints include the mean change in MADRS scores from baseline to Week 12, which will evaluate the long-term effects of the treatment. Additionally, cognitive outcomes will be assessed at both Day 28 and Week 12 to examine the impact of the treatment on cognitive function.
Interventions
Sponsors
Universita' Vita-salute S. Raffaele
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the mean change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to Day 28 (Week 4). This will assess the short-term efficacy of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include the mean change in MADRS scores from baseline to Week 12, which will evaluate the long-term effects of the treatment. Additionally, cognitive outcomes will be assessed at both Day 28 and Week 12 to examine the impact of the treatment on cognitive function. | — |
Countries
Italy
Outcome results
None listed