Actively Recruiting
Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
Led by Bjorn H. Ebdrup · Updated on 2024-12-09
46
Participants Needed
1
Research Sites
292 weeks
Total Duration
On this page
Sponsors
B
Bjorn H. Ebdrup
Lead Sponsor
L
Lundbeck Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with first episode psychosis who have not been treated or minimally treated with antipsychotics
- Diagnosis of schizophrenia spectrum or related psychotic disorders confirmed by interview
- Age between 18 and 45 years
- Legally competent to consent
- Healthy controls aged 18-45 without first-degree relatives with major psychiatric disorders
- Healthy controls legally competent to consent
You will not qualify if you...
- Prior antipsychotic use longer than two weeks in the past year or six weeks lifetime, or treatment within 30 days before inclusion
- Use of antidepressant medication within the last 7 days
- Current substance dependence or substance abuse within 3 months prior to referral (except tobacco/nicotine)
- History of head injury with more than 5 minutes unconsciousness
- Any use of coercive measures
- Presence of metal implants or pacemaker
- Head or neck tattoos
- Pregnancy
- Female patients unwilling to use effective contraception during the study
- Severe physical illness
- Allergies to ingredients in aripiprazole or memantine tablets
- Healthy controls with lifetime substance abuse/dependence or antidepressant treatment
- Healthy controls with history of head injury or metal implants
- Healthy controls pregnant or with severe physical illness
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre for Neuropsychiatric Schizophrenia Research, CNSR & Centre for Clinical Intervention & Neuropsychiatric Schizophrenia Research, CINS
Glostrup Municipality, Capitol Region, Denmark, 2600
Actively Recruiting
Research Team
B
Bjorn H Ebdrup, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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