Long-term safety study of a new bipolar medication

Plain-English translation of NCT06929273 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This is a long-term safety study of a medication called designed to treat manic episodes in people with bipolar-I disorder. Researchers want to understand how well this treatment works over time and what side effects people may experience. This study includes both people who participated in earlier testing of the medication and new participants.

While earlier studies tested whether this medication works, this trial focuses specifically on understanding its safety when people take it long-term—which is important because bipolar disorder often requires ongoing treatment.

Do you qualify?

You likely qualify if…

you have been diagnosed with bipolar-I disorder with current manic or mixed manic symptoms
you have moderate to severe manic symptoms as measured by standard rating scales
you either completed an earlier study of this medication, or you are newly joining and have not participated in previous testing
you do not currently need hospitalization for your manic symptoms
you are willing to attend study visits and follow the treatment plan

You likely don't qualify if…

you have thoughts of suicide or a recent history of suicidal behavior
you have four or more distinct mood episodes in a single year (called rapid cycling)
you have moderate to severe substance or alcohol use disorder in the past year
you have a history of severe constipation, irritable bowel syndrome requiring treatment, or difficulty urinating
you have untreated narrow-angle glaucoma or are at high risk for certain eye or stomach conditions

What participation looks like

If you join this study, you will take the medication as directed and visit the clinic for regular check-ups to monitor your symptoms and any side effects. The visits will include mood assessments and conversations with your study doctor about how you are doing. Your commitment will span several months as researchers track your long-term response to and safety on the medication.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Trial locations(173 sites)

United States

Local Institution - 0120, Glendale, Arizona

Pillar Clinical Research - Richardson, Bentonville, Arkansas

Pillar Clinical Research- Little Rock, Little Rock, Arkansas

Woodland International Research Group, Little Rock, Arkansas

Woodland Research Northwest, Rogers, Arkansas