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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Screen Pass Rate [Срок оценки: Up to 28 days]
• Exploratory Assessment-Specific Completion Rate [Срок оценки: Up to 126 days]
• Total Assessment Completion Rate [Срок оценки: Up to 126 days]
• Study Completion Rate [Срок оценки: Up to 126 days]
• Adverse Events (AEs) Including AEs of Special Interest (AESI) [Срок оценки: Up to 126 days]
• Number of Participants with Abnormalities in Vital Signs [Срок оценки: Up to 126 days]
• Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG) [Срок оценки: Up to 84 days]
• Number of Participants with Abnormalities in Laboratory Parameters [Срок оценки: Up to 84 days]
• Number of Participants Reporting Changes in Body Weight [Срок оценки: Up to 84 days]
• Number of Participants Reporting Changes in Body Mass Index (BMI) [Срок оценки: Up to 84 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 8 центров

• 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

Идентификаторы

NCT: NCT07615426 · 67953964SCH1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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