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Study of NBI-1117568 for Bipolar I Disorder with Mania

This study is testing a medication called NBI-1117568 to see if it can help adults with bipolar I disorder who are currently experiencing a manic episode. Researchers want to compare NBI-1117568 to a placebo (an inactive pill) to see how well it improves manic symptoms. You might be able to join if you are 18 to 65 years old, have been diagnosed with bipolar I disorder, have had a manic episode before, and are currently having a manic episode. The main way they will measure success is by looking at changes in your Young Mania Rating Scale (YMRS) score after 21 days. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 150 participants. It compares NBI-1117568 given by mouth to a placebo given by mouth.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Day 21, which suggests follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07288320

An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Neurocrine Biosciences
~150 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:NBI-1117568Placebo

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21
Measured over Baseline, Day 21

Conditions

Bipolar I Disorder
Mania

Explore related trials

Bipolar I disorder

Where it's being run

9 sites across 8 states
California2
Arkansas1
Florida1
Georgia1
Maryland1
New Jersey1
New York1
Texas1

Study leadership

  • Clinical Development Lead · STUDY_DIRECTOR · Neurocrine Biosciences

Who to contact

Neurocrine Medical Information Call Center
[email protected]
1-877-641-3461
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant has a primary diagnosis of bipolar I disorder.
The participant has had at least 1 prior documented manic episode that required treatment.
The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.

Exclusion

Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.
Primary diagnosis is not bipolar I disorder.
History of clozapine treatment for treatment-resistant psychosis.
History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.

What this trial measures

  • Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21Baseline, Day 21