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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
EU CTIS ID: 2024-518042-24-00
What this study is testing
The primary objective is to assess changes in cognitive functioning in schizophrenia patients starting treatment with cariprazine
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- A score of ≥ 5 on the PANSS items related to delusions (P1), conceptual disorganization (P2), and hallucinatory behavior (P3)
- Patients who participated in another trial with an investigational drug or cognitive-enhancing intervention within 90 days prior to screening
- Patients who are not fluent in the language of the cognitive batteries and questionnaires
- Pregnancy or breast-feeding
- Regularly taking centrally active medications except antipsychotics (mood stabilizers, antidepressants, etc.)
- Patients with contraindications to MRI (e.g. claustrophobia, pacemaker, non-MRI-compatible implants)
See the full eligibility criteria
- 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
- A score of ≥ 5 on the PANSS items related to delusions (P1), conceptual disorganization (P2), and hallucinatory behavior (P3)
- Patients who participated in another trial with an investigational drug or cognitive-enhancing intervention within 90 days prior to screening
- Patients who are not fluent in the language of the cognitive batteries and questionnaires
- Pregnancy or breast-feeding
- Regularly taking centrally active medications except antipsychotics (mood stabilizers, antidepressants, etc.)
- Patients with contraindications to MRI (e.g. claustrophobia, pacemaker, non-MRI-compatible implants)
- 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
- A diagnosis of alcohol and/or drug abuse or dependence as assessed through the M.I.N.I. or a positive UDS
- IQ of 70 or less as assessed through the MWT-B
- Patients who are currently treated with cariprazine or have shown insufficient response or intolerance to cariprazine in the past
- Current treatment with clozapine
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.