Status:
RECRUITING
Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
Lead Sponsor:
Bjorn H. Ebdrup
Collaborating Sponsors:
Lundbeck Foundation
Danish Research Centre for Magnetic Resonance
Conditions:
Psychosis
Negative Symptoms With Primary Psychotic Disorder
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 sym...
Detailed Description
BACKGROUND Scientific basis/Rationale Antipsychotic medication is efficacious in treating positive psychotic symptoms such as delusions, hallucinations, and disorganized thinking, which are cardinal s...
Eligibility Criteria
Inclusion
- 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')
Exclusion
- 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 substance abuse/dependence ICD-10 (F1x.1/F1x.2) (exception: tobacco/nicotine, F17.1/F17.2)
- Lifetime treatment with antidepressants
- Head injury with more than 5 minutes of unconsciousness
- Metal implanted by operation
- Head or neck tattoos
- Pacemaker
- Pregnancy (assessed by urine HCG)
- Severe physical illness
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04789915
Start Date
May 26 2021
End Date
December 31 2026
Last Update
December 9 2024
Active Locations (1)
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1
Centre for Neuropsychiatric Schizophrenia Research, CNSR & Centre for Clinical Intervention & Neuropsychiatric Schizophrenia Research, CINS
Glostrup Municipality, Capitol Region, Denmark, 2600