Title: Study of tianeptine effectiveness in treating cognitive symptoms (brain fog) in patients who have recovered from COVID-19

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What is this study about?

This study focuses on COVID fog, a condition that can occur after COVID-19 infection, characterized by problems with thinking, memory, attention, and concentration. The research evaluates the effectiveness of tianeptine, a medication that belongs to the group of psychoanaleptics, in treating these cognitive symptoms in people who have recovered from COVID-19.

The study compares tianeptine with placebo to determine if the medication can help improve cognitive function in patients experiencing COVID fog symptoms. The treatment involves taking tianeptine tablets by mouth, with a maximum daily dose of 37.5 mg over a period of 16 weeks. During the study, researchers will monitor changes in thinking abilities, memory, and other mental functions.

The research also aims to understand how COVID fog develops by examining brain function through various tests, including positron emission tomography (PET scan, a specialized imaging technique that shows how the brain is working). The study will track improvements in cognitive function, mood, sleep, and overall well-being throughout the treatment period.

1 Initial assessment

You will undergo a cognitive assessment using the Montreal Scale for the Assessment of Cognitive Function (MoCA) to confirm cognitive difficulties.

Various tests will be conducted to evaluate your cognitive functioning, including memory, attention, and problem-solving abilities.

You will complete questionnaires about your mental health, sleep quality, and general well-being.

2 Treatment assignment

You will be randomly assigned to receive either tianeptine (12.5 mg film-coated tablets) or placebo tablets.

Neither you nor the medical staff will know which treatment you are receiving during the study.

3 Treatment period

You will take the assigned medication orally for 16 weeks.

During this period, your cognitive function and other symptoms will be monitored regularly.

4 Final assessment

After 16 weeks, you will undergo final assessments including:

Repeat cognitive testing using the MoCA scale

Additional cognitive tests including CTT, COWAT, SCWT, and other memory and attention tests

Evaluation of depression symptoms using the PHQ and MADRS scales

Assessment of anxiety (GAD-7), sleep quality (AIS), and other psychological measures

5 Study completion

The study will evaluate if your cognitive function has improved by at least 2 points on the MoCA scale

Additional assessments will determine improvements in memory, attention, mood, and overall well-being

Who Can Join the Study?

Must provide written consent to participate in the study
Must be 18 years or older
Must have had a confirmed COVID-19 infection proven by either:
- A positive RT-PCR test (a laboratory test that detects the virus), or
- A positive antigen test (a rapid test that detects virus proteins)
Must report experiencing cognitive decline (problems with thinking, memory, or concentration) after COVID-19 infection
Must score less than 26 points on the Montreal Scale for the Assessment of Cognitive Function (MoCA) – this is a test that measures thinking abilities and memory
For women who can become pregnant: must use effective birth control methods during the study

Who Cannot Join the Study?

Age below 18 or above 65 years
Current pregnancy or breastfeeding
History of severe allergic reactions to medications
Serious heart conditions or uncontrolled high blood pressure
Severe liver or kidney problems
Current diagnosis of major depression or bipolar disorder
Use of antidepressants or mood-stabilizing medications in the past 2 weeks
Active substance abuse or dependence
Participation in other clinical trials within the past 30 days
Inability to provide informed consent
Diagnosis of neurological conditions other than covid fog
Severe cognitive impairment that would interfere with study procedures
History of seizures or epilepsy
Unstable medical conditions that could interfere with study participation
Known hypersensitivity to tianeptine or similar medications

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Ctiusrl Mravahow Fhrjgplsnx	Zabki	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	17.02.2023

Trial locations

Investigated drugs:

Tianeptine Sodium

Tianeptine is an antidepressant medication that works by affecting brain chemicals involved in mood and cognition. In this trial, it is being studied as a potential treatment for “covid fog” symptoms in people who have recovered from COVID-19. Covid fog refers to cognitive difficulties like memory problems, difficulty concentrating, and mental fatigue that some people experience after COVID-19 infection. The medication aims to help improve these cognitive symptoms and mental clarity in post-COVID patients.

Placebo is also used in this trial as a control substance, containing no active medication, to help determine if tianeptine is truly effective in treating covid fog symptoms.

Investigated diseases:

Post-acute COVID-19 syndrome

Post-COVID Cognitive Dysfunction – A condition that develops after COVID-19 infection, characterized by persistent cognitive impairment commonly known as “COVID fog.” The condition affects mental functioning, causing difficulties with memory, attention, and concentration. Patients experience slowed thinking processes and mental confusion that interferes with daily activities. The symptoms can include disorientation, difficulty finding words, and problems with executive functions. The condition can persist for weeks or months after the initial COVID-19 infection.

Depression – A mental health disorder marked by persistent feelings of sadness, loss of interest in activities, and changes in thinking patterns. The condition affects mood, behavior, and various physical functions including sleep and appetite. People with depression often experience difficulty concentrating, fatigue, and reduced energy levels. The disorder can develop gradually and vary in intensity.

Anxiety Disorder – A mental health condition characterized by excessive worry, unease, and fear about everyday situations. The disorder involves persistent feelings of nervousness and apprehension that can interfere with daily activities. Patients often experience physical symptoms such as rapid heartbeat, restlessness, and difficulty concentrating. The condition can manifest in various forms and intensities.

Insomnia – A sleep disorder characterized by difficulty falling asleep, staying asleep, or both. People with insomnia often experience poor sleep quality and feel unrested upon waking. The condition can affect daytime functioning, causing fatigue, difficulty concentrating, and mood changes. The disorder can be short-term or persist for longer periods.

Trial ID:

2024-510790-19-00

Protocol code:

ABM/COVMENT/2021

Trial Phase:

Therapeutic exploratory (Phase II)

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Title: Study of tianeptine effectiveness in treating cognitive symptoms (brain fog) in patients who have recovered from COVID-19

What is this study about?

Who Can Join the Study?

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