Aticaprant added to usual treatment for adults with schizophrenia
Tests the safety and tolerability of aticaprant added to treatment in schizophrenia.
Plain-language title generated from the registry record
Registry title: A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Key facts
- Where
- Atlanta, Austin, Cedarhurst, Chicago, Garden Grove, Kalamazoo, Richardson, and Staten Island, United StatesSee the 8 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07615426, who can take part
Where in United States
- Synexus Clinical Research US IncAtlanta, United StatesTaking people
- Community Clinical Research, Inc.Austin, United StatesTaking people
- Neurobehavioral Research, Inc.Cedarhurst, United StatesTaking people
- Uptown Research InstituteChicago, United StatesTaking people
- CNS NetworkGarden Grove, United StatesTaking people
- Western Michigan UniversityKalamazoo, United StatesNo longer taking part
- Pillar Clinical Research, LLCRichardson, United StatesTaking people
- Evolution Research GroupStaten Island, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07615426
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 1b Study to Investigate the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
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.
Inclusion: 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: 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.