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Study on the Effects of Vortioxetine on Cognitive Function in Patients with Early Schizophrenia

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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 the medication Vortioxetine on individuals who have been recently diagnosed with Schizophrenia or Schizophrenia spectrum disorders. Schizophrenia is a mental health condition that can affect how a person thinks, feels, and behaves. The purpose of the study is to assess how well Vortioxetine can help improve cognitive functions, which are mental processes like thinking, learning, and memory, in people with early stages of schizophrenia.

Participants in the study will receive either Vortioxetine or a standard treatment, which may include other medications such as Haloperidol, Ziprasidone, Aripiprazole, Olanzapine, Pimozide, Quetiapine, Chlorpromazine, Thioridazine, Risperidone, or Pregabalin. These medications are typically used to manage symptoms of schizophrenia and related disorders. The study will last for a period of up to 48 weeks, during which participants will take the medication orally, meaning by mouth, and their cognitive functions will be monitored and assessed at various points throughout the study.

The trial aims to determine if Vortioxetine can provide additional benefits in improving cognitive abilities compared to the usual treatments. Participants will be monitored for changes in their cognitive performance using a specific assessment tool designed for schizophrenia. This study is important for understanding how Vortioxetine might help people with schizophrenia improve their mental processes and overall quality of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the clinical trial, you will undergo an initial assessment. This involves a structured interview to confirm a diagnosis of schizophrenia spectrum disorders.
Your current medication regimen will be reviewed to ensure stability, specifically focusing on second-generation antipsychotics, excluding clozapine.
Step 2
Baseline evaluation
A baseline evaluation will be conducted to measure your cognitive functioning using the Brief Assessment of Cognition in Schizophrenia (BACS App). This will help establish a starting point for the study.
Step 3
Medication administration
You will be administered Vortioxetine orally. The dosage and frequency will be determined by the study team based on your specific needs and the study protocol.
The medication will be taken over a period of 24 weeks, with regular monitoring to assess its effects on your cognitive functioning.
Step 4
Mid-study evaluation
At week 24, a mid-study evaluation will be conducted. This involves another assessment using the BACS App to measure any changes in cognitive functioning since the baseline evaluation.
Step 5
Follow-up evaluations
Follow-up evaluations will occur at week 26 and week 50. These assessments will continue to monitor changes in your cognitive functioning and overall health.
The primary goal is to assess the effectiveness of Vortioxetine in improving cognitive impairments associated with early psychosis.
Step 6
End of study
Upon completion of the study at week 50, a final evaluation will be conducted. This will include a comprehensive assessment of your cognitive functioning and any other relevant health metrics.
The results will contribute to understanding the impact of Vortioxetine on cognitive impairments in individuals with early schizophrenia.

Who can join the trial?

12 criteria

Must be an outpatient, meaning you are not currently admitted to a hospital.
Must have a diagnosis of Schizophrenia spectrum disorders confirmed by a structured interview.
Must be between the ages of 18 and 50 years old.
Must have stable doses of antipsychotic medication for at least 4 weeks. This includes all second-generation antipsychotics except clozapine.
Must not have taken any antidepressant treatment for at least 8 weeks before starting the study.
Must have a PANSS Negative subscore greater than 14, with at least two items rated at a level of 4 or higher. PANSS is a scale used to measure symptoms of schizophrenia.
Must have a PANSS Positive subscore of 14 or less, with no more than one item rated at a level of 4 or higher.
Must have a Hamilton Depression Rating Scale (HAMD-17) total score of 12 or less. This scale measures the severity of depression symptoms.
Must have a Simpson Angus Score of less than 2 for any item. This score assesses side effects related to movement.
Must have a Behaviorally Anchored Rating Scale (BARS) score of 1 or less for any item. This scale evaluates behavior.
Must be able and willing to sign an informed consent form, indicating understanding and agreement to participate in the study.
If a woman, must agree not to become pregnant during the study and use effective birth control methods.

Who cannot join the trial?

1 criterion

Patients with a diagnosis of schizophrenia or schizophrenia spectrum disorders cannot participate.

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Virgen del Rocío University Hospital
Sevilla, Spain

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Investigated drugs

Vortioxetine is a medication being studied for its potential to help with cognitive impairments in people who have early schizophrenia. Cognitive impairments can include problems with memory, attention, and thinking skills. Vortioxetine is thought to work by affecting certain chemicals in the brain that are involved in mood and thinking processes. In this clinical trial, researchers are looking to see if Vortioxetine can improve these cognitive functions over a period of time compared to the usual treatment methods.

What is already known about the treatment

Vortioxetine – Vortioxetine is administered orally in the form of tablets. It is currently being studied for its potential benefits in treating cognitive impairments associated with early schizophrenia and schizophrenia spectrum disorders. The medication is primarily indicated for improving cognitive function in these conditions. At the molecular level, Vortioxetine works by modulating serotonin levels in the brain, which can help improve mood and cognitive processes. It is classified as an antidepressant, specifically a serotonin modulator and stimulator.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental disorder that affects how a person thinks, feels, and behaves. It is characterized by episodes of psychosis, which may include hallucinations, delusions, and disorganized thinking. Individuals with schizophrenia may also experience cognitive impairments, such as difficulties with memory, attention, and problem-solving. The progression of the disease can vary, with some individuals experiencing periods of remission and others having persistent symptoms. Over time, the disorder can lead to social withdrawal and difficulties in daily functioning. The exact cause of schizophrenia is not fully understood, but it is believed to involve a combination of genetic, brain chemistry, and environmental factors.