Study on the Safety and Effectiveness of Olanzapine for Patients with Schizophrenia

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What is this study about?

This clinical trial is focused on studying the treatment of psychosis, a mental health condition that affects how a person thinks, feels, and behaves. The treatment being studied is a medication called olanzapine, which is taken as a film-coated tablet. The purpose of the study is to understand how genetic and epigenetic factors, which are variations in genes and changes in gene activity, affect the response to olanzapine treatment in patients with psychosis.

Participants in the study will be patients diagnosed with schizophrenia or schizoaffective disorders, which are specific types of psychosis. The study will look at the frequency of certain gene variations, known as polymorphisms, in genes like CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3, and HDAC4. These genes may influence how patients respond to olanzapine. The study will also assess other factors such as the rate of treatment response, which is measured by a reduction in symptoms, and any side effects experienced during the treatment.

Throughout the study, participants will be monitored for changes in their symptoms and any side effects from the medication. The study will also track how long it takes for participants to show a response to the treatment. This research aims to provide a better understanding of how olanzapine works in treating psychosis and how individual genetic differences can affect treatment outcomes.

1 joining the study

Upon joining the study, you will be asked to provide your informed consent. This means you agree to participate and understand what the study involves.

You will need to confirm that you meet the eligibility criteria, such as being between 18 and 60 years old and having a diagnosis of schizophrenia or schizoaffective disorder.

2 initial assessment

An initial assessment will be conducted to establish a baseline for your condition. This may include various tests and questionnaires to evaluate your current health status and symptoms.

3 medication administration

You will begin or continue treatment with olanzapine, which is taken orally. The dosage and frequency will be determined by the study team based on your individual needs.

The duration of the medication administration will be specified by the study protocol, and you will be informed of any changes during the trial.

4 regular monitoring

Throughout the trial, you will have regular check-ups to monitor your response to the treatment. This includes assessing any changes in your symptoms and overall health.

You may be asked to complete questionnaires or undergo tests to evaluate the effectiveness of the treatment and any side effects.

5 genetic and epigenetic testing

As part of the study, tests will be conducted to analyze specific genes and their variations, which may affect your response to the treatment.

These tests aim to understand how genetic factors influence the effectiveness and safety of olanzapine in treating psychosis.

6 evaluation of treatment response

Your response to the treatment will be evaluated using a scale called PANSS, which measures the severity of symptoms. A reduction in your score indicates improvement.

The study will track how quickly you respond to the treatment and whether you achieve remission, which means a significant reduction in symptoms.

7 completion of the study

At the end of the study, a final assessment will be conducted to evaluate your overall progress and any changes in your condition.

You will be informed about the results of the study and any follow-up actions that may be necessary.

Who Can Join the Study?

Age between 18 and 60 years old
Diagnosed with schizophrenia or schizoaffective disorders according to the ICD-10 classification system
Currently receiving treatment with olanzapine or planning to start treatment with olanzapine
Willing to participate and have given informed consent
Women who can have children must use at least one effective method of birth control

Who Cannot Join the Study?

Patients with a history of psychoses cannot participate. Psychoses are mental health conditions that affect how a person thinks, feels, and behaves, often causing a loss of contact with reality.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fakultni Nemocnice Brno	Brno	Czechia
University Hospital Ostrava	Ostrava	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.03.2023

Trial locations

Investigated drugs:

Olanzapine

Olanzapine is a medication used to treat symptoms of schizophrenia and bipolar disorder. It helps to balance certain chemicals in the brain, which can improve mood, thoughts, and behavior. In this clinical trial, olanzapine is being studied to see how genetic and epigenetic factors might affect how well it works for different people. The goal is to understand if certain genetic traits can influence the effectiveness of olanzapine in treating psychosis.

Investigated diseases:

Schizophrenia

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. Over time, cognitive functions such as memory, attention, and problem-solving may decline. The disorder typically emerges in late adolescence or early adulthood and can affect various aspects of daily life. The exact cause is unknown, but it is believed to involve a combination of genetic, brain chemistry, and environmental factors.

Trial ID:

2022-502902-33-00

Protocol code:

SEOTP-2022

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Olanzapine for Patients with Schizophrenia

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