NCT04789915 Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
| NCT ID | NCT04789915 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bjorn H. Ebdrup |
| Condition | Psychosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2021-05-26 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 46 participants in total. It began in 2021-05-26 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients: * Antipsychotic-free(as defined under Exclusion Criteria below), first episode psychosis * Fulfilling the diagnostic criteria of schizophrenia, persistent delusional disorder, acute and transient psychotic disorders, schizoaffective disorder, other non-organic psychotic disorders and unspecified non-organic disorders (ICD-10: F20.x; F22.x; F23.x; F24.x; F25.x; F28; F29); verified by PSE interview. * Age: 18-45 years * Legally competent (In Danish: 'myndige og habile i retslig forstand') Healthy controls: * No first-degree relative with known major psychiatric disorder (ICD-10: F1x; F2x; F3x) * Age 18-45 years * Legally competent (In Danish: 'myndige og habile i retslig forstand') Exclusion Criteria: * Patients * Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime, and/or antipsychotic treatment within 30 days prior to inclusion. * Treatment with antidepressant medication the last 7 days * Current substance dependence ICD-10 (F1x.2) or substance abuse in any period up to 3 months prior to referral (exception: tobacco/nicotine, F17.2) * Head injury with more than 5 minutes of unconsciousness, lifetime * Any coercive measure * Metal implanted by operation * Head or neck tattoos * Pacemaker * Pregnancy (assessed by urine HCG) * Female patients: Unwillingness to use safe contraception (Intra Uterine Device/System or hormonal contraceptives) during the study period. * Severe physical illness * Allergies to any of the ingredients in the aripiprazole tablets or memantine tablets Healthy controls: * Lifetime substance abuse/dependence ICD-10 (F1x.1/F1x.2) (exception: tobacco/nicotine, F17.1/F17.2) * Lifetime treatment with antidepressants * Head injury with more than 5 minutes of unconsciousness * Metal implanted by operation * Head or neck tattoos * Pacemaker * Pregnancy (assessed by urine HCG) * Severe physical illness
Contact & Investigator
Olga B Baltzersen, MD
PRINCIPAL INVESTIGATOR
CNSR, Metal Health Centre Glostrup
Frequently Asked Questions
Who can join the NCT04789915 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04789915 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04789915 currently recruiting?
Yes, NCT04789915 is actively recruiting participants. Contact the research team at bebdrup@cnsr.dk for enrollment information.
Where is the NCT04789915 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark.
Who is sponsoring the NCT04789915 clinical trial?
NCT04789915 is sponsored by Bjorn H. Ebdrup. The principal investigator is Olga B Baltzersen, MD at CNSR, Metal Health Centre Glostrup. The trial plans to enroll 46 participants.