Add-on Memantine to Aripiprazole to Improve Negative Symptoms in First Episode Psychosis Patients Aged 18 to 45

What this Trial Is About

Researchers are evaluating the effects of adding memantine to initial antipsychotic treatment in patients experiencing their first episode of psychosis. This 12-week, double-blind, placebo-controlled randomized clinical trial aims to reduce negative symptoms such as lack of pleasure, motivation, and social withdrawal, which are not adequately treated by current antipsychotics. The study also examines cognitive changes, psychotic symptoms, side effects, and brain glutamate levels using advanced magnetic resonance imaging. Participants will receive either memantine or placebo tablets alongside aripiprazole, a commonly used antipsychotic medication. Memantine dosing starts at 10 mg per day for one week, then increases to 20 mg daily, while aripiprazole starts at 5-10 mg per day and can be raised to a maximum of 30 mg based on effects and side effects. The treatment period lasts 12 weeks, with healthy volunteers undergoing baseline and 12-week assessments for comparison. During the trial, participants undergo diagnostic interviews, medical and neurological exams, and screenings for pregnancy and substance use before enrollment. Researchers will monitor negative symptoms using standardized scales, cognitive function tests, psychotic symptoms, and side effects throughout. Brain glutamate levels and other metabolites will be measured at the start and end of the study using a 7 Tesla MRI scanner. The trial expects to recruit 46 patients over two years, with careful safety and adherence monitoring throughout the study.

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