Study of ALTO-300 in MDD
Purpose
The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have a diagnosis of moderate to severe major depressive disorder (MDD) - At Visit 2, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks - Willing to comply with all study assessments and procedures - Must not be pregnant or breastfeeding at time of enrollment or throughout study
Exclusion Criteria
- Evidence of unstable medical condition - Nightly use of sleep medication - Diagnosed bipolar disorder, psychotic disorder, or dementia - Current moderate or severe substance use disorder - Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients - Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ALTO-300 |
Participants will receive ALTO-300 capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open-label (OL) treatment period will receive ALTO-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks). |
|
|
Placebo Comparator Placebo |
Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Alto Neuroscience
