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Study on Clemastine and Aerobic Exercise for Improving Cognitive Function in Schizophrenia Patients

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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 combining a medication called clemastine with aerobic exercise to help improve cognitive function in individuals with schizophrenia. Schizophrenia is a mental health condition that can affect how a person thinks, feels, and behaves. The study aims to see if this combination can enhance brain function by targeting something called myelin plasticity, which is related to the protective covering of nerve fibers in the brain.

Participants in the study will receive either the medication Tavegil Tabletten, which contains clemastine, or a placebo, which looks like the medication but does not contain any active ingredients. The treatment will be taken orally in the form of tablets. The study will last for about three months, during which participants will be monitored for changes in their cognitive abilities, such as memory and overall functioning. The goal is to observe any improvements in these areas from the start to the end of the study period.

Throughout the study, various assessments will be conducted to measure changes in cognitive performance and overall mental health. These assessments include tests like the Global Assessment of Functioning (GAF) and the n-back test, which evaluates working memory. The study will also look at other factors such as physical fitness, quality of life, and any side effects that may occur. The findings from this study could provide valuable insights into new ways to support individuals with schizophrenia in managing cognitive challenges.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will begin by providing written informed consent. This is a necessary step before any study-related procedures can be conducted.
The participant must have a diagnosis of schizophrenia or a related disorder, be between 18 and 65 years old, and meet other specific health criteria.
Step 2
Initial assessment
An initial assessment will be conducted to establish baseline measurements. This includes evaluating the participant's current functioning and memory performance.
The Global Assessment of Functioning (GAF) score and working memory performance will be recorded.
Step 3
Medication administration
Participants will receive either clemastine or a placebo in tablet form. The medication is taken orally.
The treatment period lasts for 90 to 93 days, during which the participant will continue their regular antipsychotic treatment.
Step 4
Exercise regimen
Participants will engage in an aerobic exercise program designed to complement the medication treatment.
The exercise aims to improve cognitive function by targeting myelin plasticity.
Step 5
Mid-study evaluation
Throughout the study, participants will undergo regular evaluations to monitor changes in cognitive function and overall health.
These evaluations include tests for memory, attention, and other cognitive abilities.
Step 6
Final assessment
At the end of the 90 to 93-day treatment period, a final assessment will be conducted.
The primary focus will be on changes in the GAF score and working memory performance compared to the initial assessment.
Step 7
Optional follow-up
An optional follow-up visit may be conducted to assess long-term effects and any changes in remission criteria.
This visit will compare results from the end of the treatment period to the baseline measurements.

Who can join the trial?

9 criteria

The participant must provide written informed consent before any study-related procedures are done. This means they agree to take part in the study after understanding what it involves.
The participant must have a DSM-V diagnosis of schizophrenia or a related disorder. DSM-V is a guide used by doctors to diagnose mental health conditions. This diagnosis is confirmed through a MINI interview, which is a structured interview used to assess mental health disorders.
The participant must be between 18 and 65 years old.
The participant's PANSS score must be 75 or less at the initial visit (V0). PANSS stands for Positive and Negative Syndrome Scale, which is a tool used to measure symptoms of schizophrenia.
The participant must have a stable dose of antipsychotic medication for at least one week before joining the study. This means their medication and its amount have not changed during that time.
The participant must have a stable dose of CNS-active treatment (like antidepressants or mood stabilizers) for at least one week before joining the study. CNS stands for central nervous system, and these treatments affect the brain and nerves.
Female participants who can have children must have a negative pregnancy test at the screening visit. This test checks if they are pregnant.
Female participants who can have children must have a negative pregnancy test within seven days before being randomly assigned to a treatment group in the study.
Male participants and female participants who cannot have children or who use a medically approved method of contraception must meet this requirement at the screening. This means they use a reliable way to prevent pregnancy that is accepted by health authorities.

Who cannot join the trial?

8 criteria

Patients who have a different mental health condition other than schizophrenia cannot participate. Schizophrenia is a mental disorder that affects how a person thinks, feels, and behaves.
Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
Patients who are not able to give informed consent, meaning they cannot understand the study and agree to participate, are excluded.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have a history of substance abuse, which means using drugs or alcohol in a harmful way, are excluded.
Patients who have a serious medical condition that could interfere with the study or put them at risk cannot participate.
Patients who are currently participating in another clinical trial are excluded.
Patients who have had a recent change in their medication for schizophrenia cannot participate.

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Klinikum der Universitaet Muenchen AöR
Munich, Germany

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Investigated drugs

Clemastine
is an antihistamine medication that is being studied for its potential to improve cognitive function in people with schizophrenia. It is thought to work by affecting myelin, which is a protective covering around nerve fibers in the brain. This study is exploring whether clemastine can help improve memory and overall functioning in patients.
Aerobic Exercise
is a type of physical activity that increases your heart rate and breathing. In this study, aerobic exercise is being combined with clemastine to see if it can further enhance cognitive function and myelin plasticity in individuals with schizophrenia. The exercise component is designed to be a regular part of the participants' routine to assess its impact on mental health and cognitive abilities.

What is already known about the treatment

Clemastine – Clemastine is administered orally in tablet form and is currently being studied for its potential benefits in treating cognitive dysfunction in schizophrenia. It is an established antihistamine, commonly used to relieve allergy symptoms, but recent research is exploring its role in enhancing myelin plasticity, which may improve cognitive function. The medication works by blocking histamine receptors, which reduces allergic reactions, and it is being investigated for its ability to promote myelin repair in the brain. Clemastine is classified as an antihistamine and is being evaluated in combination with aerobic exercise to assess its effectiveness in improving cognitive outcomes in individuals with schizophrenia.

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, impacting their social interactions and work performance. The disorder typically emerges in late adolescence or early adulthood and can vary in severity and duration. Over time, symptoms may fluctuate, with periods of worsening and improvement. The progression of schizophrenia can lead to challenges in maintaining relationships and employment, requiring ongoing management and support.