An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NBI-1117568, Placebo.
- Who it may be relevant to
- Registry conditions: Bipolar I Disorder, Mania. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug NBI-1117568
Oral administration - Drug Placebo
Oral administration
Primary outcome measures
- Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21 [Time frame: Baseline, Day 21]
Secondary outcome measures (1)
- Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21 [Time frame: Baseline, Day 21]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Neurocrine Clinical Site — Little Rock
- Neurocrine Clinical Site — Garden Grove
- Neurocrine Clinical Site — San Diego
- Neurocrine Clinical Site — Hollywood
- Neurocrine Clinical Site — Atlanta
- Neurocrine Clinical Site — Gaithersburg
- Neurocrine Clinical Site — Marlton
- Neurocrine Clinical Site — Staten Island
- … and 1 more center
Identifiers
NCT: NCT07288320 · NBI-1117568-BPD2036