An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania (NCT07288320)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Neurocrine Clinical Site — Little Rock, Arkansas
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Neurocrine Clinical Site — Little Rock, Arkansas
- Neurocrine Clinical Site — Garden Grove, California
- Neurocrine Clinical Site — San Diego, California
- Neurocrine Clinical Site — Hollywood, Florida
- Neurocrine Clinical Site — Atlanta, Georgia
- Neurocrine Clinical Site — Gaithersburg, Maryland
- Neurocrine Clinical Site — Marlton, New Jersey
- Neurocrine Clinical Site — Staten Island, New York
- Neurocrine Clinical Site — Austin, Texas
📞 Contact the Study Coordinator
Phone: (877) 641-3461
Email: medinfo@neurocrine.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Bipolar I Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.