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RecruitingNCT07288320

Safety study of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in manic episodes in bipolarity type I

The registry lists this study as recruiting. Study locations are listed in the United States. Confirm recruitment at each site. It is testing Efficacy, Safety, and Pharmacokinetics of NBI-1117568 for manic episodes in bipolarity type I.

Bipolarity, ManiaDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

What is this study testing?

This study is testing whether NBI-1117568 may be useful for adults experiencing bipolarity.

What would participation involve?

Participants may receive NBI-1117568, complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in the United States.

Who is it mainly for?

This study appears to be mainly for adults with bipolarity.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: December 24, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
150
Sponsor
Neurocrine Biosciences
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States
Age range
From 18 Years to 65 Years
Official registry ID
NCT07288320
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

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

United States · 9 sites
  • Neurocrine Clinical Site
    Little Rock, Arkansas
    Site status: Recruiting
  • Neurocrine Clinical Site
    Garden Grove, California
    Site status: Recruiting
  • Neurocrine Clinical Site
    San Diego, California
    Site status: Recruiting
  • Neurocrine Clinical Site
    Hollywood, Florida
    Site status: Recruiting
  • Neurocrine Clinical Site
    Atlanta, Georgia
    Site status: Recruiting
  • Neurocrine Clinical Site
    Gaithersburg, Maryland
    Site status: Recruiting
  • Neurocrine Clinical Site
    Marlton, New Jersey
    Site status: Recruiting
  • Neurocrine Clinical Site
    Staten Island, New York
    Site status: Recruiting
  • Neurocrine Clinical Site
    Austin, Texas
    Site status: Recruiting

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In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. It includes a comparison with placebo. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving NBI-1117568, Placebo. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Who might this study be for?

This study may concern people with bipolarity; age range: From 18 Years to 65 Years. The criteria appear strict, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Neurocrine Biosciences, which appears to be a biotech company. The listed contact or investigator is Neurocrine Biosciences, affiliated with Neurocrine Biosciences. Sponsor website: https://www.neurocrine.com. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as recruiting. Individual sites may have different statuses. The research team must confirm whether a site is open and whether you meet the criteria.

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