RecruitingPhase 1NCT04789915

Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis

AMEND - Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis

Sponsor

Bjorn H. Ebdrup

Enrollment

46 participants

Start Date

May 26, 2021

Study Type

INTERVENTIONAL

Conditions

Psychosis Negative Symptoms With Primary Psychotic Disorder

Summary

Antipsychotics affects the brain's dopamine system, and the drugs reduce delusions, hallucinations, and disorganized thinking, which are cardinal symptoms of psychotic disorders. However, negative symptoms e.g. anhedonia, avolition, and social withdrawal, as well as cognitive deficits, are not sufficiently treated. Memantine is used to treat Alzheimer's disease and affects the brain's glutamate system. AMEND is a 12-week, double-blind, placebo-controlled, randomized clinical trial (RCT) testing effects of add-on memantine to initial antipsychotic treatment in never-treated patients with first-episode psychosis. The main aim is to reduce negative symptoms. Secondary outcomes are cognition, psychotic symptoms, side effects. Glutamate levels in the brain will be measured before and after 12 weeks using an ultra-high field strength (7 Tesla) magnetic resonance scanner. AMEND will apply rational drug repurposing to optimize treatment of patients experiencing their first psychotic episode.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding memantine — a medication commonly used for Alzheimer's disease — to standard antipsychotic treatment can improve "negative symptoms" of psychosis (such as low motivation, social withdrawal, and blunted emotions) in people experiencing their first psychotic episode. Negative symptoms are notoriously hard to treat with current medications. **You may be eligible if...** - You are between 18 and 45 years old - You have just experienced your first episode of psychosis and have not yet taken antipsychotic medication - You meet diagnostic criteria for schizophrenia or a related psychotic disorder - You are legally competent to give consent **You may NOT be eligible if...** - You have previously taken antipsychotic medication - You are outside the 18–45 age range - You are not legally competent to give consent - You do not meet the diagnostic criteria for the psychotic disorders in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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