Add-On MEmaNtine to Dopamine Antagonism to Improve Negative Symptoms at First Psychosis- the AMEND Trial Protocol.
Katharina O Sandström, Olga B Baltzersen, Anouk Marsman...
https://pubmed.ncbi.nlm.nih.gov/35669271Actively Recruiting
Phase 1
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID04789915
AMEND - Add-on Memantine to Aripiprazole to Improve Negative Symptoms in First-Episode Psychosis
Led by Bjorn H. Ebdrup · Updated on 2024-12-09
46
Participants Needed
1
Research Sites
78 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
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.
CONDITIONS
Brief Title
Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
Who Can Participate
Age: 18Years - 45Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients with antipsychotic-free first episode psychosis
- Diagnosed with schizophrenia spectrum disorders including schizophrenia, persistent delusional disorder, acute and transient psychotic disorders, schizoaffective disorder, or other non-organic psychotic disorders
- Age between 18 and 45 years
- Legally competent to consent
- Healthy controls: no first-degree relatives with major psychiatric disorders
- Healthy controls aged 18 to 45 years
- Healthy controls legally competent
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
- Antidepressant treatment in the last 7 days
- Current substance dependence or abuse within 3 months (except tobacco/nicotine)
- Head injury causing more than 5 minutes unconsciousness
- History of coercive measures
- Metal implants from operations
- Head or neck tattoos
- Pacemaker
- Pregnancy
- Female patients unwilling to use safe contraception during the study
- Severe physical illness
- Allergies to aripiprazole or memantine ingredients
- Healthy controls with lifetime substance abuse or dependence
- Healthy controls with lifetime antidepressant treatment
- Healthy controls with head injury over 5 minutes unconsciousness
- Healthy controls with metal implants, tattoos, pacemaker, pregnancy, or severe physical illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) before enrollment
Treatment
Duration - 12 weeks
Participants receive 12 weeks of treatment with aripiprazole plus either memantine or placebo. Doses of memantine or placebo start at 10 mg/day for 1 week, then increase to 20 mg/day. Aripiprazole doses start at 5-10 mg/day and may be adjusted up to 30 mg/day based on effect and side effects.
Regular visits during 12 weeks of treatment for medication administration and monitoring
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
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Research Team
B
Bjorn H Ebdrup, MD, PhD
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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