Bipolar Disorder I or II With a Major Depressive Episode study: ALTO-100
Official title ALTO-100 in Bipolar Disorder With Depression (BD-D)
ClinicalTrials.gov ID: NCT06656416
What this study is testing
What is ALTO-100?
an investigational oral tablet being studied as a potential treatment for bipolar I or II depression when added to a mood stabilizer or atypical antipsychotic
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
- This study is testing whether ALTO-100 works better than a pretend treatment for depression in people with bipolar I or II, while they also take a mood stabilizer or antipsychotic.
- Who it's for
- You may be able to join if you have bipolar I or II, are in a major depressive episode, and take a mood stabilizer or atypical antipsychotic.
- What's involved
- You would take ALTO-100 or a pretend pill, not knowing which one you get, while staying on your regular medicine. You will visit the clinic to see how you feel and to check for side effects.
- Time commitment
- The study lasts several weeks of double‑blind treatment, then an open‑label period, with regular clinic visits throughout.
- 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 is enrolling
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Chino, California, United States
- Los Angeles, California, United States
- Mather, California, United States
- Sacramento, California, United States
- San Jose, California, United States
- Colorado Springs, Colorado, United States
- Jacksonville, Florida, United States
- Pinellas Park, Florida, United States
- Tampa, Florida, United States
- Peachtree Corners, Georgia, United States
- Chicago, Illinois, United States
- Carmel, Indiana, United States
- Bel Air, Maryland, United States
- Gaithersburg, Maryland, United States
- Towson, Maryland, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
+ 25 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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Chino, California, United States; Los Angeles, California, United States; Mather, California, United States; Sacramento, California, United States and 39 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.