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Recruiting NCT07615426

A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia

Phase I Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aticaprant, Placebo.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Aticaprant
    Participants will receive aticaprant during the double blind (DB) treatment phase.
  • Drug Placebo
    Participants will receive placebo during the DB treatment phase.

Primary outcome measures

  • Screen Pass Rate [Time frame: Up to 28 days]
  • Exploratory Assessment-Specific Completion Rate [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 84 days]
  • Number of Participants with Abnormalities in Laboratory Parameters [Time frame: Up to 84 days]
  • Number of Participants Reporting Changes in Body Weight [Time frame: Up to 84 days]
  • Number of Participants Reporting Changes in Body Mass Index (BMI) [Time frame: Up to 84 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 8 centers
  • CNS Network — Garden Grove
  • Synexus Clinical Research US Inc — Atlanta
  • Uptown Research Institute — Chicago
  • Western Michigan University — Kalamazoo
  • Neurobehavioral Research Inc — Cedarhurst
  • Evolution Research Group — Staten Island
  • Community Clinical Research, Inc. — Austin
  • Pillar Clinical Research, LLC — Richardson

Identifiers

NCT: NCT07615426 · 67953964SCH1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗