Bipolar I DisorderPhase 2NCT07288320
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
A Phase 2 study testing NBI-1117568 in people with Bipolar I Disorder and Mania, run by Neurocrine Biosciences at 11 sites in United States.
Trial summary
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder, Mania
- What is being tested?
- NBI-1117568
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 Dec 2025to Feb 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Neurocrine Clinical Site
Atlanta, Georgia, 30331
- Recruiting
Neurocrine Clinical Site
Austin, Texas, 78754
- Recruiting
Neurocrine Clinical Site
Cerritos, California, 90703
- Recruiting
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877
- Recruiting
Neurocrine Clinical Site
Garden Grove, California, 92845
- Recruiting
Neurocrine Clinical Site
Hollywood, Florida, 33024
- Recruiting
Neurocrine Clinical Site
Houston, Texas, 77043
- Recruiting
Neurocrine Clinical Site
Little Rock, Arkansas, 72211
- Recruiting
Neurocrine Clinical Site
Marlton, New Jersey, 08053
- Recruiting
Neurocrine Clinical Site
San Diego, California, 92123
- Recruiting
Neurocrine Clinical Site
Staten Island, New York, 10314
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.
- Conditions
- Bipolar I Disorder, Mania
- Being tested
- NBI-1117568, Placebo
- Keywords
- Bipolar I Disorder, Mania, NBI-1117568
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-1117568Drug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| NBI-1117568 | Experimental | Participants will receive NBI-1117568. Receives: Drug: NBI-1117568 |
| Placebo | Placebo comparator | Participants will receive placebo matching NBI-1117568. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21
Measured: Baseline, Day 21
Secondary outcomes (1)
Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21
Measured: Baseline, Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start24 Dec 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288320
- Sponsor's protocol ID
- NBI-1117568-BPD2036
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No