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ID del estudio CN012-0006  |   NCT07686263

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

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Lo sentimos, este estudio aún no acepta participantes.
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Resumen

  • Phase 3
  • Ícono de género masculino y femenino
  • 18-65
  • 44
  • Ícono de BMS, estudio No reclutando aún
    Not Yet Recruiting

Descripción general

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
  • Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
    1. Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
      1. Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
        1. Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution)
          1. Participant must have a CGI-S score of ≥ 4 at screening and Day -1
            1. Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

              Criterios de exclusión

              Criterios de exclusión Icon
              • Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
                1. Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
                  1. Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
                    1. Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
                      1. Participant must not have a history of treatment resistance to schizophrenia medications
                        1. Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
                          Información Adicional *
                          • Other protocol-defined Inclusion/Exclusion criteria apply.

                            Opciones de tratamiento

                            Brazos del estudio

                            INTERVENCIÓN ASIGNADA

                            Brazos del estudio

                            Experimental: KarXT

                            INTERVENCIÓN ASIGNADA
                            • Drug: Xanomeline/Trospium Chloride

                            Brazos del estudio

                            Placebo Comparator: Placebo

                            INTERVENCIÓN ASIGNADA
                            • Drug: Placebo
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