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New treatment option for Psychosis
Official title Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
ClinicalTrials.gov ID: NCT04789915
What this study is testing
What is Memantine?
Memantine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for psychosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Patients:
- Antipsychotic-free(as defined under
You likely can't join if
- below), first episode psychosis
- Fulfilling the diagnostic criteria of schizophrenia, persistent delusional disorder, acute and transient psychotic disorders, schizoaffective...
- 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
See the full eligibility criteria
- Patients:
- Antipsychotic-free(as defined under
- 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...
- 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 Criteria:
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup Municipality, Capitol Region, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup Municipality, Capitol Region, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.