RECRUITING

NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Talk to us

Conditions

Schizophrenia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

Quick Facts

Study Start:2025-08-11
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07105098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant has a primary diagnosis of schizophrenia
  2. * Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
  3. * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
  4. * Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements
  1. * Participant has known hypersensitivity to any component of the formulation of NBI-1117568
  2. * Participant has an unstable or poorly controlled medical condition or chronic disease
  3. * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
  4. * 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
  5. * Participant has a positive alcohol test or drug screen for disallowed substances
  6. * Participant has a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Contacts and Locations

Study Contact

Neurocrine Medical Information Call Center
CONTACT
877-641-3461
medinfo@neurocrine.com

Principal Investigator

Clinical Development Lead
STUDY_DIRECTOR
Neurocrine Biosciences

Study Locations (Sites)

Neurocrine Clinical Site
Culver City, California, 90230
United States
Neurocrine Clinical Site
Garden Grove, California, 92845
United States
Neurocrine Clinical Site
Riverside, California, 92506
United States
Neurocrine Clinical Site
Atlanta, Georgia, 30328
United States
Neurocrine Clinical Site
North Canton, Ohio, 44720
United States

Collaborators and Investigators

Sponsor: Neurocrine Biosciences

  • Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11
Study Completion Date2027-11

Study Record Updates

Study Start Date2025-08-11
Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia