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

Conditions

First episode psychosis; ICD-10: F20.x; F22.x; F23.x; F24.x; F25.x; F28; F29

Brief summary

Primary Endpoints Primary endpoint will be reduction in negative symptoms as measured with Positive and Negative Syndrome Scale (PANSS) negative symptoms after 12 weeks of treatment [PANSS negative baseline - PANSS negative at week 12]. Assessments will be supplemented by Brief Negative Symptom Scale (BNSS) scores.

Detailed description

changes in cognition (in particular working memory, set-shifting, and attention), Change in PANSS positive and PANSS total, clinical measures, level of functioning, side effects, glutamate levels in five a priori selected regions: thalamus, anterior cingulate cortex (ACC), hippocampus, dorsolateral prefrontal cortex (DLPFC), and basal ganglia., Exploratory endpoints include associations between clinical data, quality of life, brain metabolites in other regions, e.g. ACC, and structural measures (e.g. hippocampus subfields), and basal ganglia quantification (See Table 1 for detailed assessments). Interactions between baseline brain metabolite levels and brain structure in patients and HC will also be investigated.

Related papers

No related papers found yet.

Interventions

DRUGMEMANTINE

DRUGARIPIPRAZOLE

DRUGCoated tablets to match memantine (10/20mg)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Primary Endpoints Primary endpoint will be reduction in negative symptoms as measured with Positive and Negative Syndrome Scale (PANSS) negative symptoms after 12 weeks of treatment [PANSS negative baseline - PANSS negative at week 12]. Assessments will be supplemented by Brief Negative Symptom Scale (BNSS) scores.	—

Secondary

Measure	Time frame
changes in cognition (in particular working memory, set-shifting, and attention), Change in PANSS positive and PANSS total, clinical measures, level of functioning, side effects, glutamate levels in five a priori selected regions: thalamus, anterior cingulate cortex (ACC), hippocampus, dorsolateral prefrontal cortex (DLPFC), and basal ganglia., Exploratory endpoints include associations between clinical data, quality of life, brain metabolites in other regions, e.g. ACC, and structural measures (e.g. hippocampus subfields), and basal ganglia quantification (See Table 1 for detailed assessments). Interactions between baseline brain metabolite levels and brain structure in patients and HC will also be investigated.	—

Measure

Time frame

changes in cognition (in particular working memory, set-shifting, and attention), Change in PANSS positive and PANSS total, clinical measures, level of functioning, side effects, glutamate levels in five a priori selected regions: thalamus, anterior cingulate cortex (ACC), hippocampus, dorsolateral prefrontal cortex (DLPFC), and basal ganglia., Exploratory endpoints include associations between clinical data, quality of life, brain metabolites in other regions, e.g. ACC, and structural measures (e.g. hippocampus subfields), and basal ganglia quantification (See Table 1 for detailed assessments). Interactions between baseline brain metabolite levels and brain structure in patients and HC will also be investigated.

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Countries

Denmark

Outcome results

None listed