Testing a new medication for manic episodes in bipolar disorder

Plain-English translation of NCT06951698 on ClinicalTrials.gov ↗ · Source last updated April 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 Phase 3 clinical trial testing a new medication called to treat acute manic episodes in people with bipolar-I disorder. You would stay in the hospital for 3 weeks while taking either the medication or a placebo (an inactive pill), and researchers would carefully monitor how well it works and whether it's safe. The entire study, including screening, treatment, and follow-up, would last about 7 weeks.

Manic episodes in bipolar-I disorder can be severe and disruptive, and current treatment options don't work equally well for everyone. This trial is testing whether this medication could offer a new, potentially more effective option for people experiencing acute mania.

Do you qualify?

You likely qualify if…

you have been diagnosed with bipolar-I disorder by a psychiatrist
you are currently experiencing an acute manic episode or a manic episode with mixed mood features that started within the last 3 weeks
you require hospitalization because of your current manic symptoms
your manic symptoms are severe enough to meet specific rating scales used in the study
you are able to stop taking your current psychiatric medications safely before the study begins

You likely don't qualify if…

you have been diagnosed with bipolar-II disorder, rapid-cycling bipolar disorder, or other primary psychiatric disorders in the past year
you have a substance use disorder (other than tobacco) or have used drugs or alcohol recently
you have a history of serious constipation, urinary problems, or narrow-angle glaucoma
you are at significant risk for suicide based on clinical assessment
you have irritable bowel syndrome or have needed treatment for severe constipation in the past 6 months

What participation looks like

You would be admitted to a hospital for a 3-week treatment period. During this time, you would receive either or a placebo in flexible doses, meaning the research team would adjust your dose based on how you respond and tolerate the medication. Researchers would regularly assess your manic symptoms using standardized rating scales and monitor your safety. After the 3-week inpatient period, you would have follow-up visits to ensure you remain stable before the study ends.

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

Trial locations(63 sites)

United States

Pillar Clinical Research - Bentonville, Bentonville, Arkansas

Woodland International Research Group, Little Rock, Arkansas

Advanced Research Center Inc., Anaheim, California

CITrials, Bellflower, California

Local Institution - 0014, Cerritos, California