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New treatment option for Bipolar Disorder I or II With a Major Depressive Episode
Official title ALTO-100 in Bipolar Disorder With Depression (BD-D)
ClinicalTrials.gov ID: NCT06656416
What this study is testing
What is ALTO-100?
ALTO-100 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bipolar disorder i or ii with a major depressive episode.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Yuma, Arizona, United States
- Fayetteville, Arkansas, United States
- Little Rock, Arkansas, United States
- Imperial, California, United States
- Los Angeles, California, United States
- Mather, California, United States
- Oceanside, California, United States
- Riverside, California, United States
- Colorado Springs, Colorado, United States
- Lauderhill, Florida, United States
- Atlanta, Georgia, United States
- Peachtree Corners, Georgia, United States
- Baltimore, Maryland, United States
- Bel Air, Maryland, United States
- Gaithersburg, Maryland, United States
- Lincoln, Nebraska, United States
- Las Vegas, Nevada, United States
- Toms River, New Jersey, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Phoenix, Arizona, United States; Yuma, Arizona, United States; Fayetteville, Arkansas, United States; Little Rock, Arkansas, United States; Imperial, California, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.