Cariprazine for Schizophrenia

Inclusion criteria

• {"criterion_text":"- Diagnosis of schizophrenia as defined by ICD-10 as determined by the M.I.N.I."}
• {"criterion_text":"- Age 18-65 years"}
• {"criterion_text":"- Without hospitalization due to worsening of psychosis and without any modification in psychopharmacological treatment for at least 8 weeks"}
• {"criterion_text":"- In need of adjustment of the current oral antipsychotic treatment as judged by the treating psychiatrist"}
• {"criterion_text":"- CGI-S baseline score ≥ 4"}
• {"criterion_text":"- Capable of providing written informed consent"}

Exclusion criteria

• {"criterion_text":"- A score of ≥ 5 on the PANSS items related to delusions (P1), conceptual disorganization (P2), and hallucinatory behavior (P3)"}
• {"criterion_text":"- Presence of predominant negative symptoms (PANSS FSNS >24 and PANSS FSPS <19) to avoid pseudospecificity"}
• {"criterion_text":"- Presence of clinically significant extrapyramidal symptoms, defined a score of ≥ 3 on one of the subscales of the St. Hans Rating Scale (global hyperkinesia subscale, global parkinsonism subscale, dystonia subscale, akathisia subscale) and/or the use of anticholinergics for the treatment of extrapyramidal motor symptoms"}
• {"criterion_text":"- Presence of clinically significant symptoms of depression, defined as a total score of ≥ 11 on the CDSS"}
• {"criterion_text":"- Active suicidal ideation as measured through the C-SSRS, defined as an answer of ‘Yes’ to items 4 and/or 5"}
• {"criterion_text":"- A diagnosis of alcohol and/or drug abuse or dependence as assessed through the M.I.N.I. or a positive UDS"}
• {"criterion_text":"- IQ of 70 or less as assessed through the MWT-B"}
• {"criterion_text":"- Patients who are currently treated with cariprazine or have shown insufficient response or intolerance to cariprazine in the past"}
• {"criterion_text":"- Current treatment with clozapine"}
• {"criterion_text":"- Patients who participated in another trial with an investigational drug or cognitive-enhancing intervention within 90 days prior to screening"}
• {"criterion_text":"- Patients who are not fluent in the language of the cognitive batteries and questionnaires"}
• {"criterion_text":"- Pregnancy or breast-feeding"}
• {"criterion_text":"- Regularly taking centrally active medications except antipsychotics (mood stabilizers, antidepressants, etc.)"}
• {"criterion_text":"- Patients with contraindications to MRI (e.g. claustrophobia, pacemaker, non-MRI-compatible implants)"}

Primary endpoints

• {"endpoint_text":"- To investigate changes in the BACS and HFERST scores and in fMRI data from baseline to week 28","definition_or_measurement_approach":"Change from baseline to week 28 in BACS and HFERST scores and in fMRI data (i.e. longitudinal assessment of cognitive test scores and fMRI measures over 28 weeks)."}

Secondary endpoints

• {"endpoint_text":"- Longitudinal changes in the following measures: 1. PANSS 2. NSA-4 3. CGI 4. CDRS 5. SHRS/SMARTS 6. MARS 7. PSP 8. EQ-5D","definition_or_measurement_approach":"Longitudinal changes (over study visits) in the listed clinical rating scales and patient-reported outcome instruments."}

Austria

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

29-10-2024

Processing Time Days

47

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Medizinische Universitaet Innsbruck

Organisation Type

Educational Institution

Country Of Registered Address

Austria