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RECRUITING
NCT04789915
PHASE1

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

Sponsor: Bjorn H. Ebdrup

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2021-05-26

Completion Date

2026-12-31

Last Updated

2024-12-09

Healthy Volunteers

Yes

Interventions

DRUG

Memantine

Add on treatment with memantine to aripiprazole.

DRUG

Placebo

Placebo add on to aripiprazole

Locations (1)

Centre for Neuropsychiatric Schizophrenia Research, CNSR & Centre for Clinical Intervention & Neuropsychiatric Schizophrenia Research, CINS

Glostrup Municipality, Capitol Region, Denmark