2024-518042-24-00RecruitingPhase 4
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Jun 2026
Brief summary (registry, in English)
The primary objective is to assess changes in cognitive functioning in schizophrenia patients starting treatment with cariprazine
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 3 Oct 2024
- Start date
- 21 Mar 2021
- Lead sponsor
- Medizinische Universitaet Innsbruck
- Diseases
- Schizophrenia
- EU CT number
- 2024-518042-24-00
- EudraCT number
- 2020-005726-29
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with schizophrenia whose current oral antipsychotic treatment needs to be adjusted. It studies how cariprazine affects thinking skills.
- Age
- 18-65 years
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia (ICD-10). No hospital stay for worse psychosis and no change in drug treatment for at least 8 weeks. Needs a treatment adjustment, with a CGI-S baseline score of 4 or higher.
- Earlier treatment
- Must be on an oral antipsychotic that the treating psychiatrist says needs adjusting. Cannot have been treated with cariprazine before with poor response or side effects, or be on it now. Cannot be on clozapine now.
Main reasons for not taking part
- Severe delusions, disorganized thinking or hallucinations (PANSS score of 5 or higher)
- Mainly negative symptoms
- Regular use of other brain-acting drugs, such as mood stabilizers or antidepressants
- Pregnancy or breast-feeding
- Active suicidal thoughts, alcohol or drug abuse, or IQ of 70 or less
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck | Innsbruck | Austria | Recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH | Salzburg | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.