NCT04789915RecruitingPhase 1
Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
AMEND - Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 25 Feb 2021
- Start date
- 26 May 2021
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Bjorn H. Ebdrup
- Diseases
- Schizophrenia
- NCT number
- NCT04789915
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 46
- From 26 May 2021 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 treatment with antidepressants
Other illness
- Severe physical illness
Other
- Lifetime substance abuse/dependence ICD-10 (F1x.1/F1x.2) (exception: tobacco/nicotine, F17.1/F17.2)
- Head injury with more than 5 minutes of unconsciousness
- Metal implanted by operation
- Head or neck tattoos
- Pacemaker
- Pregnancy (assessed by urine HCG)
Who the study is looking for
- 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')
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Neuropsychiatric Schizophrenia Research, CNSR & Centre for Clinical Intervention & Neuropsychiatric Schizophrenia Research, CINS Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.