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

NCT04789915 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Psychosis
  • Negative Symptoms With Primary Psychotic Disorder

Interventions

DRUG

Memantine

Add on treatment with memantine to aripiprazole.

DRUG

Placebo

Placebo add on to aripiprazole

Sponsors & Collaborators

  • Lundbeck Foundation

    collaborator OTHER

  • Danish Research Centre for Magnetic Resonance

    collaborator OTHER

  • Bjorn H. Ebdrup

    lead OTHER

Principal Investigators

  • Olga B Baltzersen, MD · CNSR, Metal Health Centre Glostrup

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2025-07-01
Completion
2026-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789915 on ClinicalTrials.gov