Schizophrenia study: NBI-1117568
Official title Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
ClinicalTrials.gov ID: NCT07227818
What this study is testing
What is NBI-1117568?
An investigational oral capsule being studied for the prevention of relapse in adults with schizophrenia.
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 study compares NBI-1117568 with a placebo to see if it can delay a return of schizophrenia symptoms in adults who have already responded to the drug during an earlier open‑label phase.
- Who it's for
- Adults who have schizophrenia and have shown a stable response to NBI-1117568 in a prior open‑label treatment.
- What's involved
- Participants will receive either NBI-1117568 or a placebo and will have regular clinic visits and symptom assessments to monitor for relapse.
- Time commitment
- The study lasts several months, with scheduled visits throughout the treatment period to track symptoms and safety.
- Phase 3: a large, late-stage study
- 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 schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical...
- Participant had the initial diagnosis of schizophrenia ≥1 year before screening.
- Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose. Key
You likely can't join if
- Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological [including dementing...
- Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease.
- Participant has a history of clozapine treatment for treatment-resistant psychosis.
- Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to...
- Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is...
The study team makes the final eligibility decision.
Where it is enrolling
- Garden Grove, California, United States
- La Habra, California, United States
- Lemon Grove, California, United States
- Oceanside, California, United States
- Torrance, California, United States
- Hollywood, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Flowood, Mississippi, United States
- Marlton, New Jersey, United States
- Cedarhurst, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- DeSoto, Texas, United States
- Bellevue, Washington, United States
- San Juan, Puerto Rico
+ 2 more site(s).
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, but 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?
This study is enrolling now at Garden Grove, California, United States; La Habra, California, United States; Lemon Grove, California, United States; Oceanside, California, United States; Torrance, California, United States; Hollywood, Florida, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.