Recruiting
Phase 1

Aticaprant

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07615426

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Aticaprant

Placebo

Study Details

Brief summary:

The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.

Conditions

Schizophrenia

Study ID

NCT07615426

Start date

Mar 2, 2026

Status verified date

Aug, 2026

Completion date

Jul 5, 2027

Anticipated

Primary completion date

Jun 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview \[MINI\] for psychotic disorders
  • The participant must be on a stable dose of only one atypical antipyschotic medication
  • Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening
  • At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit
  • If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double blind treatment phase

Exclusion criteria:

  • Has one or more of the current or prior (lifetime) diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnoses (based on the MINI for psychotic disorders): intellectual disability, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, psychotic disorder not otherwise specified (NOS), substance-induced psychotic disorder, bipolar disorder, major depressive disorder (recurrent or current episode)
  • Has a history of moderate-to-severe substance use disorder, including alcohol use disorder, according to DSM-5 criteria within 6 months before screening except for nicotine or caffeine (based on the MINI and clinical judgment)
  • Current cannabis (marijuana, pot, grass, hash, etcetera) use exceeds 3 to 5 times over the past 30 days as measured by items from the national survey on drug use and health (NSDUH) questionnaire
  • Has a history in the past 6 months of a peptic ulcer, or lifetime history of upper gastrointestinal bleeding, or known untreated helicobacter pylori infection, or has a diagnosis of zollinger-ellison syndrome (ZES)
  • Has current homicidal ideation/intent, per the investigator's clinical judgment

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Aticaprant

Participants will receive aticaprant during the double blind (DB) treatment phase.

placebo comparator: Arm B: Placebo

Participants will receive placebo during the DB treatment phase.

Interventions

Aticaprant

Participants will receive aticaprant during the double blind (DB) treatment phase.

Placebo

Participants will receive placebo during the DB treatment phase.

Primary outcome measure

  • Screen Pass Rate [ Time Frame: Up to 28 days ]
  • Exploratory Assessment-Specific Completion Rate [ Time Frame: Up to 126 days ]
  • Total Assessment Completion Rate [ Time Frame: Up to 126 days ]
  • Study Completion Rate [ Time Frame: Up to 126 days ]
  • Adverse Events (AEs) Including AEs of Special Interest (AESI) [ Time Frame: Up to 126 days ]
  • Number of Participants with Abnormalities in Vital Signs [ Time Frame: Up to 126 days ]
  • Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG) [ Time Frame: Up to 84 days ]
  • Number of Participants with Abnormalities in Laboratory Parameters [ Time Frame: Up to 84 days ]
  • Number of Participants Reporting Changes in Body Weight [ Time Frame: Up to 84 days ]
  • Number of Participants Reporting Changes in Body Mass Index (BMI) [ Time Frame: Up to 84 days ]
  • Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time [ Time Frame: Up to 126 days ]
  • Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score [ Time Frame: Up to 84 days ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

CNS Network

Recruiting

Garden Grove, California, United States, 92845

Synexus Clinical Research US Inc

Recruiting

Atlanta, Georgia, United States, 30328

Uptown Research Institute

Recruiting

Chicago, Illinois, United States, 60640

Western Michigan University

Recruiting

Kalamazoo, Michigan, United States, 49008

Neurobehavioral Research Inc

Recruiting

Cedarhurst, New York, United States, 11516

Evolution Research Group

Recruiting

Staten Island, New York, United States, 10314

Community Clinical Research, Inc.

Recruiting

Austin, Texas, United States, 78754

Pillar Clinical Research, LLC

Recruiting

Richardson, Texas, United States, 75080

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.