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Tests treatment safety and results for Bipolar I Disorder
Official title An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
ClinicalTrials.gov ID: NCT07288320
What this study is testing
What is NBI-1117568?
NBI-1117568 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bipolar i disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Garden Grove, California, United States
- Hollywood, California, United States
- San Diego, California, United States
- Atlanta, Georgia, United States
- Gaithersburg, Maryland, United States
- Marlton, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garden Grove, California, United States; Hollywood, California, United States; San Diego, California, United States; Atlanta, Georgia, United States; Gaithersburg, Maryland, United States; Marlton, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.