Phase 4 Schizophrenia Trial, Recruiting NCT05316883 Sponsor: Jimmi Nielsen Condition: Schizophrenia
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Phase 4 Schizophrenia Trial, Recruiting

NCT05316883
Recruiting Phase 4

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:

  • You have been diagnosed with schizophrenia, chronic paranoid psychosis, schizoaffective disorder, or another non-organic psychosis (based on recognised medical diagnosis codes)
  • You are between 18 and 65 years old
  • You are legally able to make your own decisions and give consent
  • You have been on a stable antipsychotic medication for at least the past month
  • Your condition has not responded well enough to at least two different antipsychotic medications, each tried at an adequate dose for at least 6 weeks, and you still have a moderate level of symptoms
  • Occasional recreational use of substances is acceptable, as long as it does not affect your ability to follow the study requirements
  • If you are a woman who could become pregnant, you must be using a reliable form of contraception, such as a hormonal method or an intrauterine device (IUD/coil)

Who may not be able to join:

  • You are currently admitted to a psychiatric facility involuntarily (against your will)
  • You have a substance abuse problem that would affect your ability to follow the study requirements
  • You are currently pregnant (women who could become pregnant will be asked to take a urine pregnancy test)
  • You have previously had a severe and dangerous drop in white blood cells caused by medication or an unusual reaction
  • A recent blood test shows your bone marrow is not functioning well enough
  • You currently have epilepsy that is not well controlled
  • You currently have circulatory collapse or significant suppression of the central nervous system for any reason (confirm with trial site)
  • You currently have severe kidney, heart, or liver disease
  • You currently have a condition called paralytic ileus, where the bowel has stopped working (confirm with trial site)

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 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Jimmi Nielsen, PhD, Mental health Service, Glostrup

Phone: 4538640885

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 4
Sponsor
Jimmi Nielsen
Registry
ClinicalTrials.gov
Start date
28 February 2021
Est. completion
31 December 2029

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Qalb; Change in Qalb; Change in IL-6 and TGF-beta

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: 26 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