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Study on the Effects of Cariprazine on Cognitive Function in Schizophrenia Patients Needing Antipsychotic Treatment Adjustment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called cariprazine on cognitive functioning in patients with schizophrenia. Schizophrenia is a mental health disorder that affects a person's ability to think, feel, and behave clearly. The medication being tested, cariprazine, is taken in the form of hard capsules and is also known by the code name RGH-188. The purpose of the study is to assess changes in cognitive functioning in patients with schizophrenia who need an adjustment in their oral antipsychotic treatment.

During the study, participants will begin treatment with cariprazine and will be monitored over a period of 28 weeks. The study will observe changes in cognitive abilities, which are the mental processes involved in gaining knowledge and understanding, such as thinking, knowing, remembering, and judging. Participants will not be hospitalized due to worsening of psychosis and will not have any changes in their psychopharmacological treatment for at least 8 weeks prior to the study. The study aims to provide insights into how cariprazine may help improve cognitive functioning in individuals with schizophrenia.

Throughout the study, various assessments will be conducted to evaluate the effects of cariprazine. These assessments will include tests and measures that help understand changes in cognitive abilities and overall mental health. The study will also involve the use of imaging techniques like fMRI (functional Magnetic Resonance Imaging) to observe brain activity. The results of this study may contribute to better understanding and management of cognitive symptoms in schizophrenia, potentially leading to improved treatment options for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of schizophrenia and ensuring no recent changes in medication or hospitalization.
The assessment will also involve a review of the current treatment plan and the need for adjustment as determined by the psychiatrist.
Step 2
Consent and baseline evaluation
Written informed consent will be obtained to ensure understanding and agreement to participate in the study.
A baseline evaluation will be conducted, including cognitive tests and other assessments to measure current functioning levels.
Step 3
Medication administration
The study involves taking Reagila 1.5 mg hard capsules orally. The medication is administered daily as part of the treatment plan.
The duration of medication administration is up to 28 weeks, with regular monitoring and adjustments as needed.
Step 4
Regular follow-up visits
Regular follow-up visits will be scheduled to monitor progress and any changes in symptoms or side effects.
These visits will include cognitive assessments and other evaluations to track changes over time.
Step 5
Final assessment
At the end of the 28-week period, a final assessment will be conducted to evaluate the overall effects of the treatment.
This will include a comprehensive review of cognitive functioning and any other relevant measures.

Who can join the trial?

6 criteria

Diagnosis of schizophrenia as defined by ICD-10, determined by a specific interview called the M.I.N.I.
Age between 18 and 65 years
No hospital stays due to worsening of symptoms and no changes in medication for at least 8 weeks
Need for adjustment of current oral antipsychotic medication, as decided by the treating psychiatrist
CGI-S baseline score of 4 or higher (CGI-S is a scale used to measure the severity of symptoms)
Ability to provide written informed consent

Who cannot join the trial?

3 criteria

Patients who do not have a diagnosis of schizophrenia.
Patients who are not within the age range of 18 to 65 years old.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Medizinische Universitaet Innsbruck
Innsbruck, Austria
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Uniklinikum Salzburg
Salzburg, Austria

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Investigated drugs

Cariprazine is a medication used in this clinical trial to help improve cognitive functioning in patients with schizophrenia. Schizophrenia is a mental health condition that can affect how a person thinks, feels, and behaves. Cariprazine is an antipsychotic medication, which means it helps to manage symptoms of schizophrenia by affecting certain chemicals in the brain. In this trial, the focus is on how cariprazine might help improve thinking skills, such as memory and attention, in patients who need changes in their current antipsychotic treatment.

Cariprazine

What is already known about the treatment

Cariprazine – Cariprazine is an oral medication used to treat schizophrenia, a mental health condition characterized by distorted thinking and perceptions. It is taken by mouth in the form of a capsule. Currently, cariprazine is well-established in medical practice and literature as an effective treatment for schizophrenia. Its main therapeutic indication is to help manage symptoms of schizophrenia, including hallucinations and delusions. At the molecular level, cariprazine works by affecting certain chemicals in the brain, particularly dopamine and serotonin, which are involved in mood and behavior. It is classified pharmacologically as an atypical antipsychotic.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. It often manifests through symptoms such as hallucinations, delusions, disorganized thinking, and significant social or occupational dysfunction. The progression of schizophrenia can vary, with some individuals experiencing episodes of acute symptoms followed by periods of remission, while others may have a more continuous course. Cognitive impairments, such as difficulties with memory, attention, and problem-solving, are common and can worsen over time. Negative symptoms, including reduced emotional expression and lack of motivation, may also become more pronounced as the disease progresses. The course of schizophrenia is highly individualized, with varying degrees of symptom severity and functional impact.