Using memantine to improve negative symptoms in first-episode psychosis
AMEND - Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
This study is testing if adding memantine to regular antipsychotic treatment can help people experiencing their first episode of psychosis feel better by reducing negative symptoms like lack of pleasure and social withdrawal.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Glostrup Municipality, Capitol Region) |
| Trial ID | NCT04789915 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of adding memantine, a drug typically used for Alzheimer's disease, to standard antipsychotic treatment in patients experiencing their first episode of psychosis. The study is a 12-week, double-blind, placebo-controlled randomized trial focusing on reducing negative symptoms such as anhedonia and social withdrawal, which are often inadequately addressed by current antipsychotic medications. Participants will undergo brain imaging using a 7 Tesla MRI to measure glutamate levels before and after treatment, providing insights into the drug's effects on brain chemistry. The goal is to optimize treatment strategies for patients with psychotic disorders by exploring the glutamate hypothesis of psychosis.
Who should consider this trial
Good fit: Ideal candidates are antipsychotic-free individuals aged 18-45 experiencing their first episode of psychosis.
Not a fit: Patients with a history of antipsychotic use exceeding specified limits or those with major psychiatric disorders in first-degree relatives may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of negative symptoms in patients with first-episode psychosis.
How similar studies have performed: While the use of memantine in this context is relatively novel, previous studies have indicated potential benefits of targeting glutamatergic dysregulation in psychosis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glostrup Municipality, Capitol Region
- Centre for Neuropsychiatric Schizophrenia Research, CNSR & Centre for Clinical Intervention & Neuropsychiatric Schizophrenia Research, CINS — Glostrup Municipality, Capitol Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Olga B Baltzersen, MD — CNSR, Metal Health Centre Glostrup
- Study coordinator: Bjorn H Ebdrup, MD, PhD
- Email: bebdrup@cnsr.dk
- Phone: +4538640840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.