Not Yet Recruiting
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia - CN012-0006
Aggiornato:
30 giugno, 2026
|
ClinicalTrials.gov.
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Dettagli della sperimentazione
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Phase 3
Fase
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Sesso
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18-65
Fascia d'età
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44
Sede/i
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Not Yet Recruiting
Opzioni di trattamento
Principali criteri di idoneità
Inclusion Criteria - 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. - Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date. - Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -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) - Participant must have a CGI-S score of ≥ 4 at screening and Day -1 - Participant must have a BMI ≥ 18 and ≤ 40 kg/m2. Exclusion Criteria - Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening - Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia. - 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). - Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening. - Participant must not have a history of treatment resistance to schizophrenia medications - Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%. - Other protocol-defined Inclusion/Exclusion criteria apply.