ALTO-100 in Bipolar Disorder with Depression (BD-D)
Purpose
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
Condition
- Bipolar Disorder I or II with a Major Depressive Episode
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have a diagnosis of BD-I or BD-II as well as BD-D - At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA 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 - Concurrent use of any prohibited medications or substance use disorder - Diagnosed psychotic disorder (other than mania or depression) - Current moderate or severe substance use disorder - Has a history of hypersensitivity or allergic reaction to ALTO-100 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-100 |
Participants will receive ALTO-100 40 mg tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. Eligible participants who enter the open label (OL) treatment period will receive ALTO-100 40 mg tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks). |
|
|
Placebo Comparator Placebo DB |
Participants will receive matching placebo tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Alto Neuroscience
