Phase 1 Schizophrenia Trial, Recruiting NCT04789915 Sponsor: Bjorn H. Ebdrup Condition: Schizophrenia
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Phase 1 Schizophrenia Trial, Recruiting

NCT04789915
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people experiencing a first episode of psychosis:

  • People who are experiencing their first episode of psychosis and have not recently taken antipsychotic medication (see exclusion details below)
  • People who have been diagnosed with a psychotic disorder such as schizophrenia, delusional disorder, schizoaffective disorder, or a related condition, confirmed through a structured interview
  • People aged 18 to 45 years
  • People who are legally considered capable of making their own decisions

For healthy volunteers (people without a psychotic disorder):

  • People who have no close family members (parents, siblings, or children) with a known major psychiatric condition
  • People aged 18 to 45 years
  • People who are legally considered capable of making their own decisions

Who may not be able to join:

For people experiencing a first episode of psychosis:

  • People who have previously taken antipsychotic medication for more than two weeks in the past year, more than six weeks across their lifetime, or any antipsychotic medication within the 30 days before joining
  • People who have taken antidepressant medication in the last 7 days
  • People who currently have a substance dependency, or who had significant substance misuse problems in the three months before being referred to the trial (note: tobacco and nicotine use is an exception)
  • People who have ever had a head injury that caused more than 5 minutes of unconsciousness
  • People currently subject to any involuntary (coercive) psychiatric measures
  • People who have metal surgically implanted in their body
  • People who have tattoos on their head or neck
  • People who have a pacemaker
  • People who are pregnant (checked by a urine test)
  • Female patients who are unwilling to use a reliable form of contraception (such as an IUD or hormonal contraceptives) for the duration of the study
  • People with a serious physical illness
  • People with allergies to any ingredients in aripiprazole or memantine tablets (the study medications)

For healthy volunteers:

  • People who have ever had a problem with substance misuse or dependency (note: tobacco and nicotine use is an exception)
  • People who have ever been treated with antidepressant medication
  • People who have ever had a head injury causing more than 5 minutes of unconsciousness
  • People who have metal surgically implanted in their body
  • People who have tattoos on their head or neck
  • People who have a pacemaker
  • People who are pregnant (checked by a urine test)
  • People with a serious physical illness

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Olga B Baltzersen, MD, CNSR, Metal Health Centre Glostrup

Phone: +4538640840

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Bjorn H. Ebdrup
Registry
ClinicalTrials.gov
Start date
26 May 2021
Est. completion
1 July 2025

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Negative Symptom change, PANSS negative subscore; Negative Symptom change, Brief Negative Symptom Scale (BNSS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov