A Phase 1 interventional study of Aticaprant and Placebo in Schizophrenia, sponsored by Janssen Research & Development, LLC. Recruiting at 8 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 64 is close to the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive aticaprant during the double blind (DB) treatment phase.
Drug: Aticaprant
Participants will receive placebo during the DB treatment phase.
Drug: Placebo
Participants will receive aticaprant during the double blind (DB) treatment phase.
Also known as: JNJ-67953964
Participants will receive placebo during the DB treatment phase.
Screen Pass Rate
Screening pass rate of participants will be reported.
Time frame: Up to 28 days
Exploratory Assessment-Specific Completion Rate
Assessment specific completion rate of participants will be reported.
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 and including 85 days
Number of Participants with Abnormalities in Laboratory Parameters
Time frame: Up to and including 85 days
Number of Participants Reporting Changes in Body Weight
Time frame: Up to and including 85 days
Number of Participants Reporting Changes in Body Mass Index (BMI)
Time frame: Up to and including 85 days
Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time
The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the occurrence and intensity of suicidal thoughts and suicidal behaviors.
Time frame: Up to 126 days
Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score
Time frame: Up to and including 85 days
Not enrolling at this site.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Aticaprant
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