A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT07615426
- Run by
- Janssen Research & Development, LLC
- People needed
- 64
- Starts
- 2026-03-02
- Expected to finish
- 2027-07-05
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CNS Network — Garden Grove, California, United States (enrolling)
- Synexus Clinical Research US Inc — Atlanta, Georgia, United States (enrolling)
- Uptown Research Institute — Chicago, Illinois, United States (enrolling)
- Western Michigan University — Kalamazoo, Michigan, United States (enrolling)
- Neurobehavioral Research Inc — Cedarhurst, New York, United States (enrolling)
- Evolution Research Group — Staten Island, New York, United States (enrolling)
- Community Clinical Research, Inc. — Austin, Texas, United States (enrolling)
- Pillar Clinical Research, LLC — Richardson, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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