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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people with schizophrenia whose condition is stable. It compares aticaprant, added to their usual treatment, with a placebo to check safety and side effects. It also looks at how easy it is to enroll people and have them finish study visits and tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stable schizophrenia, confirmed through a mental health interview.
  • Take a steady dose of just one atypical antipsychotic, a type of medicine for schizophrenia.
  • Get schizophrenia care from a mental health provider without staying in a hospital when screened.
  • Have a screening blood test that shows you are taking an antipsychotic medicine allowed by the study.
  • If you take medicine for depression or anxiety, keep the same dose for 8 weeks before screening and during the phase when neither you nor the study team knows which treatment you get.

Who can't join

  • Have ever had an intellectual disability, which affects learning and daily living skills.
  • Have ever had schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, unspecified psychotic disorder, or substance-induced psychotic disorder. These are other conditions that affect how a person thinks or understands reality.
  • Have ever had bipolar disorder, or have current or repeated major depression.
  • Have had a moderate or severe alcohol or drug use disorder in the past 6 months, except for nicotine or caffeine.
  • Have used marijuana more than 3 to 5 times in the past 30 days.
  • Have had a stomach or upper intestine ulcer in the past 6 months, or have ever had bleeding in the upper digestive tract.
  • Have a known, untreated H. pylori infection, a stomach infection, or Zollinger-Ellison syndrome, which causes too much stomach acid.
  • Currently have thoughts of killing someone or intend to do so, based on the study doctor's judgment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (8)

CA

GA

IL

MI

NY

TX