Study on Memantine and Aripiprazole for Reducing Negative Symptoms in Patients with First Episode Psychosis

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What is this study about?

This clinical trial is focused on studying the effects of adding the medication Memantine to the treatment of individuals experiencing their first episode of psychosis. Psychosis is a mental health condition that can cause symptoms like delusions, hallucinations, and disorganized thinking. While current treatments, known as antipsychotics, help manage these symptoms by affecting the brain’s dopamine system, they often do not fully address other issues such as lack of pleasure, motivation, and social withdrawal, which are known as negative symptoms. Memantine, a drug commonly used to treat Alzheimer’s disease, works on the brain’s glutamate system and is being tested to see if it can help reduce these negative symptoms when added to the initial antipsychotic treatment.

The purpose of this study is to determine if adding Memantine can improve the treatment of negative symptoms in patients with first episode psychosis. The study will last for 12 weeks and is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or a placebo. Participants will be randomly assigned to receive either Memantine or a placebo in addition to their regular antipsychotic medication. The main goal is to see if there is a reduction in negative symptoms after 12 weeks of treatment.

Throughout the study, changes in cognitive functions like memory and attention will also be monitored, along with overall clinical measures and any side effects. The study will also explore how Memantine affects certain brain regions involved in psychosis. This research aims to provide a better understanding of how to effectively treat negative symptoms in psychosis, potentially improving the quality of life for those affected by this condition.

1 joining the trial

Upon joining the trial, you will be randomly assigned to receive either the study medication or a placebo. This process is called randomization and ensures that the study results are unbiased.

You will be informed about the medication you will be taking, which could be memantine hydrochloride or a placebo. Memantine is a medication that affects the brain’s glutamate system and is used to treat symptoms of Alzheimer’s disease.

2 medication administration

You will take the medication orally in the form of coated tablets. The dosage will be either 10 mg or 20 mg, depending on the specific requirements of the trial.

The medication will be taken daily for a duration of 12 weeks. It is important to follow the dosage instructions provided by the study team.

3 regular assessments

Throughout the 12-week trial, you will undergo regular assessments to monitor your symptoms and any changes in your condition.

These assessments will include evaluations of negative symptoms using the Positive and Negative Syndrome Scale (PANSS) and the Brief Negative Symptom Scale (BNSS).

4 cognitive and clinical evaluations

In addition to symptom assessments, your cognitive functions such as memory, attention, and problem-solving will be evaluated.

Clinical measures will also be taken to assess your overall level of functioning and any side effects you may experience.

5 end of trial

At the end of the 12-week period, a final assessment will be conducted to evaluate the overall impact of the medication on your symptoms.

The results will help determine the effectiveness of adding memantine to the initial antipsychotic treatment for individuals experiencing their first episode of psychosis.

Who Can Join the Study?

Must be experiencing a first episode of psychosis. This means it is the first time the person is having symptoms like delusions (strong beliefs that are not true), hallucinations (seeing or hearing things that are not there), or disorganized thinking.
Must not have taken antipsychotic medication before. Antipsychotic medications are drugs used to manage symptoms of psychosis.
Must meet the diagnostic criteria for certain mental health conditions, such as schizophrenia or other related disorders. These are verified through a specific type of interview called a PSE interview.
Must be between the ages of 18 and 45 years.
Must be legally competent, meaning the person is legally able to make their own decisions.

Who Cannot Join the Study?

Patients who have not experienced a first episode of psychosis. This means the study is only for those who are experiencing their first occurrence of psychotic symptoms.
Patients who are not within the specified age range for the study. The study is designed for a specific age group.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other medical conditions that might interfere with the study or make participation unsafe.
Patients who are currently participating in another clinical trial or have recently participated in one.
Patients who are pregnant or breastfeeding, as the study medication may not be safe for the baby.
Patients who have a history of severe allergic reactions to the study medication or similar drugs.
Patients who have a history of substance abuse that might interfere with the study results.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Region Hovedstadens Psykiatriske	Glostrup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	08.05.2024

Trial locations

Investigated drugs:

Memantine is a medication that is commonly used to treat Alzheimer’s disease. It works by affecting the brain’s glutamate system, which is involved in memory and learning. In this clinical trial, memantine is being tested as an additional treatment to help improve negative symptoms in patients who are experiencing their first episode of psychosis. These negative symptoms can include things like lack of pleasure, lack of motivation, and social withdrawal. The goal is to see if adding memantine to the initial antipsychotic treatment can help reduce these symptoms.

Investigated diseases:

Psychotic disorder

First Episode Psychosis – This condition marks the initial occurrence of psychotic symptoms in an individual. It is characterized by delusions, hallucinations, and disorganized thinking. These symptoms can disrupt a person’s perception of reality and affect their ability to function in daily life. Over time, individuals may also experience negative symptoms such as reduced motivation, social withdrawal, and diminished emotional expression. Cognitive deficits, including problems with memory and attention, may also develop. The progression of these symptoms can vary widely among individuals.

Trial ID:

2024-513878-21-02

NCT ID:

NCT04789915

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Memantine and Aripiprazole for Reducing Negative Symptoms in Patients with First Episode Psychosis

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