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A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Clinicaltrials.gov:
J&J ID:
#67953964SCH1001
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Trials at a glance
Status
Enrolling
Condition
Schizophrenia
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
Aticaprant
Placebo
Age
18 to 55 years old
Biological sex
All
Placebo?
Yes
Trial start date
March 2, 2026
Trial end date
June 21, 2027
CT.gov ID
#NCT07615426
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study of 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.
Primary outcome measures
- Screen Pass Rate
- Exploratory Assessment-Specific Completion Rate
- Total Assessment Completion Rate
- Study Completion Rate
- Adverse Events (AEs) Including AEs of Special Interest (AESI)
- Number of Participants with Abnormalities in Vital Signs
- Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
- Number of Participants with Abnormalities in Laboratory Parameters
- Number of Participants Reporting Changes in Body Weight
- Number of Participants Reporting Changes in Body Mass Index (BMI)
- Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time
- Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score
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