ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Purpose
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Condition
- Treatment-resistant Depression (TRD)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF. - Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe). - Failure to respond (<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment) - Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
Exclusion Criteria
- Evidence of unstable medical condition - Concurrent use of any prohibited medications or substance use disorder - Diagnosed bipolar disorder or a psychotic disorder or symptoms - Significant current PTSD symptoms or history of PTSD - Clinically significant current impulse control difficulties - Has a history of hypersensitivity or allergic reaction to ALTO-207 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-207 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Alto Neuroscience
