An open label signal detection study to evaluate the effects of cariprazine on cognitive functioning in patients with schizophrenia in need of adjustment of oral antipsychotic treatment
Key facts
- Where
- Innsbruck és Salzburg, AusztriaSee the 2 sites
- Phase
- 4. fázis
Where in Ausztria
- Medizinische Universitaet InnsbruckInnsbruck, AusztriaTaking people
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbHSalzburg, AusztriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medizinische Universitaet Innsbruck
- Trial code
- EU 2024-518042-24-00
- Record updated
- 2026. június 22.
- Original description
The primary objective is to assess changes in cognitive functioning in schizophrenia patients starting treatment with cariprazineRead full original descriptionShow less
The primary objective is to assess changes in cognitive functioning in schizophrenia patients starting treatment with cariprazine
Inclusion: Diagnosis of schizophrenia as defined by ICD-10 as determined by the M.I.N.I; Age 18-65 years; Without hospitalization due to worsening of psychosis and without any modification in psychopharmacological treatment for at least 8 weeks; In need of adjustment of the current oral antipsychotic treatment as judged by the treating psychiatrist; CGI-S baseline score ≥ 4; Capable of providing written informed consent.
Exclusion: Patients who participated in another trial with an investigational drug or cognitive-enhancing intervention within 90 days prior to screening; Regularly taking centrally active medications except antipsychotics (mood stabilizers, antidepressants, etc.); Patients with contraindications to MRI (e.g. claustrophobia, pacemaker, non-MRI-compatible implants); A diagnosis of alcohol and/or drug abuse or dependence as assessed through the M.I.N.I. or a positive UDS; Patients who are currently treated with cariprazine or have shown insufficient response or intolerance to cariprazine in the past; Current treatment with clozapine; A score of ≥ 5 on the PANSS items related to delusions (P1), conceptual disorganization (P2), and hallucinatory behavior (P3); Patients who are not fluent in the language of the cognitive batteries and questionnaires; Pregnancy or breast-feeding; Presence of predominant negative symptoms (PANSS FSNS >24 and PANSS FSPS <19) to avoid pseudospecificity; 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; Presence of clinically significant symptoms of depression, defined as a total score of ≥ 11 on the CDSS; Active suicidal ideation as measured through the C-SSRS, defined as an answer of ‘Yes’ to items 4 and/or 5; IQ of 70 or less as assessed through the MWT-B.