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RecruitingPhase 2

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

Neurocrine Biosciences · NCT07288320

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
150
US sites recruiting
11
Study start
December 24, 2025
Record last updated
September 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: NBI-1117568; Placebo

Conditions: Bipolar I Disorder; Mania

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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.

Key Exclusion Criteria

  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Neurocrine Medical Information Call Center · 1-877-641-3461 · medinfo@neurocrine.com
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An Assessment of Efficacy, Safety, and Pharmacokinetics of… (NCT07288320) | Bored Studies