Using memantine to improve negative symptoms in first-episode psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of adding memantine, a drug typically used for Alzheimer's disease, to standard antipsychotic treatment in patients experiencing their first episode of psychosis. The study is a 12-week, double-blind, placebo-controlled randomized trial focusing on reducing negative symptoms such as anhedonia and social withdrawal, which are often inadequately addressed by current antipsychotic medications. Participants will undergo brain imaging using a 7 Tesla MRI to measure glutamate levels before and after treatment, providing insights into the drug's effects on brain chemistry. The goal is to optimize treatment strategies for patients with psychotic disorders by exploring the glutamate hypothesis of psychosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 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

Where it's running

• Centre for Neuropsychiatric Schizophrenia Research, CNSR & Centre for Clinical Intervention & Neuropsychiatric Schizophrenia Research, CINS
  Glostrup Municipality, Capitol Region, Denmark Recruiting

Study contacts

• Principal investigator: Olga B Baltzersen, MD — CNSR, Metal Health Centre Glostrup
• Study coordinator: Bjorn H Ebdrup, MD, PhD
• Email: bebdrup@cnsr.dk
• Phone: +4538640840

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.