Clinical Trials in the USA / NCT07615426
Recruiting
Phase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
NCT07615426 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Schizophrenia
Investigational drug(s) / intervention(s)
AticaprantPlacebo
Aticaprant: Participants will receive aticaprant during the double blind (DB) treatment phase.
Placebo: Participants will receive placebo during the DB treatment phase.
Study 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.
Eligibility
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
Primary outcome measure(s)
- Screen Pass Rate — Up to 28 days
Screening pass rate of participants will be reported. - Exploratory Assessment-Specific Completion Rate — Up to 126 days
Assessment specific completion rate of participants will be reported. - Total Assessment Completion Rate — Up to 126 days
- Study Completion Rate — Up to 126 days
- Adverse Events (AEs) Including AEs of Special Interest (AESI) — Up to 126 days
- Number of Participants with Abnormalities in Vital Signs — Up to 126 days
- Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG) — Up to and including 85 days
- Number of Participants with Abnormalities in Laboratory Parameters — Up to and including 85 days
- Number of Participants Reporting Changes in Body Weight — Up to and including 85 days
- Number of Participants Reporting Changes in Body Mass Index (BMI) — Up to and including 85 days
- Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time — Up to 126 days
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. - Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score — Up to and including 85 days
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| CNS Network | Garden Grove | California | Recruiting |
| Synexus Clinical Research US Inc | Atlanta | Georgia | Recruiting |
| Uptown Research Institute | Chicago | Illinois | Recruiting |
| Western Michigan University | Kalamazoo | Michigan | Completed |
| Neurobehavioral Research Inc | Cedarhurst | New York | Recruiting |
| Evolution Research Group | Staten Island | New York | Recruiting |
| Community Clinical Research, Inc. | Austin | Texas | Recruiting |
| Pillar Clinical Research, LLC | Richardson | Texas | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07615426 on ClinicalTrials.gov ↗ ← All trials in the USA