NCT06963034 · Neurocrine Biosciences
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
What this study is about
The primary objective for this study is to evaluate the effectiveness of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
View original scientific description
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
Interventions
DRUG
NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
DRUG
Placebo
Placebo will be administered per schedule specified in the arm description.
Primary outcome measures
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Time frame: Baseline, Week 5
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant has a primary diagnosis of schizophrenia
- Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
- Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
- Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements Key
Exclusion criteria
- Participant has known hypersensitivity to any component of the formulation of NBI-1117568.
- Participant has an unstable or poorly controlled medical condition or chronic disease
- Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
- Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening
- Participant has a positive alcohol test or drug s
Where
- Bryant, Arkansas
- Little Rock, Arkansas
- Anaheim, California
- Pico Rivera, California
- San Diego, California
- Sherman Oaks, California
- Torrance, California
- Hollywood, Florida
- Miami Lakes, Florida
- Atlanta, Georgia
- Decatur, Georgia
- Snellville, Georgia
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 6, 2026 · Source of record for eligibility and locations