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ALTO-100 for Bipolar Depression

Phase 2

Recruiting

Research Sponsored by Alto Neuroscience

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Evidence of unstable medical condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed 4 times over a 6-week interval, from day 1 to week 6

Summary

This trial aims to compare the effectiveness of ALTO-100 and a placebo in treating depression in patients with bipolar disorder. The study will also look at the safety and effectiveness of ALTO-100 in

Who is the study for?

This trial is for individuals with bipolar disorder (either type I or II) who are currently experiencing a major depressive episode. Participants must be on a mood stabilizer to join the study. Specific details about what excludes someone from participating aren't provided here.

What is being tested?

The study is testing the effectiveness of ALTO-100 compared to a placebo in reducing symptoms of depression in bipolar disorder when taken alongside standard mood stabilizers. It includes an initial double-blind phase followed by an open label period where all participants know they're receiving ALTO-100.

What are the potential side effects?

While specific side effects are not detailed, common ones may include typical antidepressant-related issues such as nausea, headaches, sleep disturbances, and potential mood swings or changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with bipolar disorder.

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I've been on a stable dose of a mood stabilizer for at least 6 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a medical condition that is currently not stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed 4 times over a 6-week interval, from day 1 to week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed 4 times over a 6-week interval, from day 1 to week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 4 times over a 6-week interval, from day 1 to week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary study objectives

To assess efficacy of ALTO-100 vs placebo for depressive symptoms in MDD in a pre-defined subgroup as measured by the change from Day 1 to Week 6 in response (>50% improvement from baseline) and remission (total score of <10) rates based on MADRS

To assess efficacy of ALTO-100 vs placebo for self-reported depressive symptoms in bipolar disorder patients in a pre- defined subgroup of participants as measured by the change from Day 1 to Week 6 in Patient Health Questionnaire, 9 item (PHQ-9)

To assess efficacy of ALTO-100 vs placebo in severity of bipolar disorder symptoms in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 in Clinician Global Impression Scale-severity (CGI-S)

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALTO-100Experimental Treatment1 Intervention

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).

Group II: Placebo DBPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met