Testing a New Medication for Manic Episodes in Bipolar-I Disorder

Plain-English translation of NCT06951698 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 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 medication called to see if it can safely and effectively treat the symptoms of a manic episode in people with bipolar-I disorder. You would stay in a hospital for 3 weeks while taking either the new medication or a placebo (an inactive pill), and researchers would measure how much your manic symptoms improve. This is an important final stage of testing before the medication could potentially become available to patients.

Current treatments for manic episodes don't work well enough for everyone, and this medication may offer a new option. Researchers want to confirm that this treatment is safe and truly effective at reducing mania symptoms.

Do you qualify?

You likely qualify if…

you have been diagnosed with bipolar-I disorder
you are currently experiencing an acute manic episode or mania with mixed features that started within the last 3 weeks
you require hospitalization because of your current manic symptoms
you are willing to stop taking your other psychiatric medications before the study begins (within 14 days)
your manic symptoms are at a moderate-to-severe level, confirmed by specific rating scales your doctors will use

You likely don't qualify if…

you have been diagnosed with other primary mental health conditions besides bipolar-I disorder (such as bipolar-II, borderline personality disorder, or primary psychosis) in the past year
you have a history of rapid cycling, meaning you experience 4 or more distinct mood episodes within a single year
you have a moderate-to-severe substance use disorder, or have tested positive for drugs or alcohol recently
you have a current or recent history of serious constipation, irritable bowel syndrome, urinary retention, or narrow-angle glaucoma
you are at risk for suicide, as determined by your doctor and a clinical assessment tool

What participation looks like

You would be admitted to a hospital for approximately 3 weeks, during which you would take either or a placebo once daily at a dose tailored to you. Neither you nor your doctors would know which treatment you're receiving. During your stay, doctors would regularly assess your manic symptoms using rating scales and monitor you for any side effects. After the 3-week treatment period, you would have a brief follow-up visit to check on your safety and well-being. The entire study, including screening and follow-up, takes no more than 7 weeks.

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

Trial locations(73 sites)

United States

Local Institution - 0058, Bentonville, Arkansas

Woodland International Research Group, Little Rock, Arkansas

Advanced Research Center Inc., Anaheim, California

CITrials, Bellflower, California

Local Institution - 0014, Cerritos, California