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Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis

ConditionsPsychosisNegative Symptoms With Primary Psychotic Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBjorn H. Ebdrup

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Antipsychotic-free(as defined under

Disqualifiers

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')

No first-degree relative with known major psychiatric disorder (ICD-10: F1x; F2x; F3x)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Memantine

    Drug

    Add on treatment with memantine to aripiprazole.

  • Placebo

    Drug

    Placebo add on to aripiprazole

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Memantine + aripiprazoleActive comparator 1 intervention
Group B: Placebo + aripiprazolePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Negative Symptom change, PANSS negative subscore

Change in negative symptoms measured on the Positive and negative syndrome scale (PANSS), negative symptom subscore total. Scale from 7 to 49, lower values indicating better outcome.

Time frame
12 weeks
2

Negative Symptom change, Brief Negative Symptom Scale (BNSS)

Change in negative symptoms measured on the Brief Negative Symptom Scale (BNSS). Scale from 0 to 90, lower values indicating better outcome.

Time frame
12 weeks

Secondary outcomes

1

PANSS total

Overall clinical effect measured on Positive and negative syndrome scale (PANSS) total. Scale from 30 to 210, lower values indicating better outcome.

Time frame
12 weeks
2

PANSS positive

Change in positive symptoms measured on the Positive and negative syndrome scale (PANSS), positive symptom subscore total. Scale from 7 to 49, lower values indicating better outcome.

Time frame
12 weeks
3

Cognition, CANTAB

Change in cognitive measurements: Cambridge Neuropsychological Test Automated Battery (CANTAB)

Time frame
12 weeks
4

Cognition, BACS

Change in cognitive measurements: Brief Assessment of Cognition in Schizophrenia (BACS): memory, working memory, processing speed, executive functions and verbal fluency

Time frame
12 weeks

Other outcomes

1

Quality of life, self rated by patients

Measured on quality of life scale (QLS), by patients. Scale with 21 items, from 0 to 4, total scores from 0 to 84. Higher scores indicating a better quality of life.

Time frame
12 weeks
2

MR exploratory outcomes, spectroscopy

Spectroscopy data (glutamate and GABA concentrations) from other regions

Time frame
12 weeks
3

MR exploratory outcomes, structural data 1

MR structural measurements, volumetric data of thalamus

Time frame
12 weeks
4

MR exploratory outcomes, structural data 2

MR structural measurements, volumetric data of anterior cingulate cortex (ACC)

Time frame
12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bjorn H. Ebdrup

Lead sponsor

University of Copenhagen

Sponsor institution

Lundbeck Foundation

Collaborator

Danish Research Centre for Magnetic Resonance

Collaborator

Source ClinicalTrials.gov
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