ALTO-100 in Bipolar Disorder with Depression (BD-D)

Alto Neuroscience

Status and phase

Enrolling

Phase 2

Conditions

Bipolar Disorder I or II with a Major Depressive Episode

Treatments

Drug: Placebo

Drug: ALTO-100

Study type

Interventional

Funder types

Industry

Identifiers

NCT06656416

ALTO-100-211

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups, including a placebo group

ALTO-100

Experimental group

Description:

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).

Treatment:

Drug: ALTO-100

Placebo DB

Placebo Comparator group

Description:

Participants will receive matching placebo tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period.

Treatment:

Drug: Placebo