AMEND - Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
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.
• 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')