Not recruiting

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

Registered drug

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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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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).
Step 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.
Step 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 trial?

5 criteria

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 trial?

8 criteria

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.

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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.

What is already known about the treatment

Memantine – Memantine is administered orally and is typically taken in tablet form. It is currently used in medicine to treat Alzheimer's disease by affecting the brain's glutamate system. In the context of clinical trials, memantine is being tested as an add-on treatment to antipsychotics for patients experiencing their first episode of psychosis. The main goal is to improve negative symptoms such as lack of pleasure, lack of motivation, and social withdrawal, which are not adequately addressed by standard antipsychotic medications. Memantine works by modulating the activity of glutamate, a key neurotransmitter in the brain, which may help improve these symptoms. It is classified as an NMDA receptor antagonist in pharmacology.

Investigated diseases

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.