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Region Hovedstaden - en del af Københavns Universitetshospital

Add-on MEmaNtine do Dopamine antagonism to improve negative symptoms at first psychosis - AMEND

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Early intervention improves long term outcome in patients with psychosis, however antipsychotic drugs remain inadequate for treatment of negative and cognitive symptoms. In patients with chronic schizophrenia memantine, a non-competitive glutamatergic (NMDA) antagonist, shows promise for ameliorating negative symptoms and improving cognition.
However, the neurobiology of NMDA modulation is unknown, and memantine has not been investigated in first-episode patients.
AMEND is a 12-week, double-blind, placebo-controlled, randomized clinical trial (RCT)testing clinical- and neurobiological effects of add-on memantine to the antidopaminergic antipsychotic drug, amisulpride, in antipsychotic-naïve patients with first-episode psychosis. Brain metabolite levels will be measured with ultra-high magnetic field strength (7 Tesla)
proton magnetic resonance spectroscopy before and after 12 weeks.
Primary endpoint is negative symptoms. Secondary outcomes are cognition, psychotic symptoms, side effects, and brain glutamate levels.
We hypothesize that add-on memantine will be superior to amisulpride in monotherapy to reduce negative symptoms, and we expect higher baseline thalamic glutamate levels to predict treatment response to memantine.
With the ambitious goal of moving clinical psychiatry towards pre-treatment stratification based on pathophysiological markers, AMEND will provide evidence for rational drug repurposing to optimize treatment outcome for patients with psychosis.
FinansieringskildePrivat fond (Privat)
Beløb4.999.812,00 Danske Kroner

ID: 61762252