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Study on Tolcapone for Improving Cognitive Symptoms in Patients with Long-Standing Schizophrenia

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Tasmar, which contains the active ingredient tolcapone. The study is specifically looking at its potential benefits for people with schizophrenia, a mental health condition that affects how a person thinks, feels, and behaves. The trial aims to see if tolcapone can help improve cognitive functions, such as memory and attention, and reduce negative symptoms in individuals with long-standing schizophrenia. These symptoms might include a lack of motivation or reduced emotional expression.

The study is based on a specific genetic variation known as the rs4680 polymorphism of the COMT enzyme gene. This genetic factor may influence how well tolcapone works in improving cognitive abilities in patients. Participants in the study will take Tasmar in the form of film-coated tablets, and the medication will be administered orally. The trial will compare the effects of tolcapone with a placebo to determine its effectiveness.

Throughout the study, participants will undergo various assessments to measure changes in their cognitive performance and brain activity. These assessments may include tests like the DPX cognitive test and brain imaging techniques such as functional MRI (fMRI). The study will also evaluate the participants’ overall well-being and any changes in their symptoms using clinical scales. The trial is designed to last for a specific period, during which participants will be closely monitored to ensure their safety and to gather comprehensive data on the effects of tolcapone.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a clinical interview to verify the diagnosis of schizophrenia and ensure the patient is in the clinical compensation phase.

Eligibility criteria include being between 18-65 years old, having a diagnosis of schizophrenia for at least 5 years, and being of Caucasian origin. Women of childbearing age must have a negative pregnancy test.

2 medication administration

The patient will receive Tasmar 100 mg film-coated tablets, which contain the active substance tolcapone. The medication is taken orally.

The dosage and frequency of administration will be determined by the study protocol and communicated to the patient by the study team.

3 cognitive and clinical assessments

Throughout the trial, the patient will undergo various assessments to evaluate cognitive function and clinical symptoms.

Primary assessments include performance on the DPX cognitive test and the modified MATRICS battery, as well as brain activation measured by functional MRI (fMRI).

Secondary assessments involve clinical scales such as PANSS, NSA-16, and others, along with patient-reported outcomes and plasma homocysteine levels.

4 ongoing monitoring

The patient’s health and response to the medication will be monitored regularly. This includes tracking any side effects and adjusting the treatment plan as necessary.

Regular follow-up visits will be scheduled to ensure the patient’s well-being and adherence to the study protocol.

5 completion of the trial

The trial is expected to conclude by April 30, 2025. Upon completion, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

Results from the trial will contribute to understanding the efficacy of tolcapone as a cognitive enhancer in patients with schizophrenia.

Who Can Join the Study?

  • Ability to provide informed consent and express your desire to follow all study requirements during the study period. This means you understand what the study involves and agree to participate.
  • The patient must be able, in the opinion of the study doctor, to follow all the requirements of the clinical trial.
  • Age between 18-65 years.
  • Patients must have been diagnosed with schizophrenia according to DSM-5, which is a guide used by doctors to diagnose mental health conditions. Only patients who have had the disease for 5 years or more will be included. Patients must be in a stable phase of their condition, meaning they are not experiencing severe symptoms and have not been hospitalized for psychiatric reasons in the past year. Their overall functioning score, called the Global Activity Assessment Scale (GAF), should be 60 or higher in the last month. A clinical interview will confirm the diagnosis.
  • Patients must be of Caucasian origin.
  • If the patient is a woman who can have children, she must have a negative pregnancy test.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of schizophrenia cannot participate. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves.
  • Patients who are not in the clinical compensation phase of schizophrenia cannot participate. This phase means the symptoms are stable and under control.
  • Patients who are not experiencing cognitive impairment or negative symptoms related to schizophrenia cannot participate. Cognitive impairment refers to difficulties with thinking, memory, and understanding. Negative symptoms include lack of motivation, reduced emotional expression, and social withdrawal.
  • Patients who do not have the specific genetic makeup related to the rs4680 polymorphism of the COMT enzyme gene cannot participate. This is a specific genetic variation that may affect how the body processes certain substances.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
08.09.2014

Trial locations

Investigated drugs:

Tolcapone is being studied to see if it can help improve thinking and reduce negative symptoms in people with long-term schizophrenia. The trial is looking at how well this medication works based on a specific genetic marker in patients.

Investigated diseases:

Schizophrenia – Schizophrenia is a chronic mental health disorder that affects how a person thinks, feels, and behaves. It often involves symptoms such as hallucinations, delusions, and disorganized thinking. Individuals with schizophrenia may experience a reduced ability to function in daily life. The disease typically progresses with episodes of psychosis, where the person loses touch with reality. Negative symptoms, such as lack of motivation and social withdrawal, can also be present. Cognitive impairments, including difficulties with memory and attention, are common and can worsen over time.

Trial ID:
2024-511433-35-00
Protocol code:
rs4680-tolcapona
Trial Phase:
Therapeutic exploratory (Phase II)

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