Phase 4 Schizophrenia Trial, Recruiting NCT05958875 Sponsor: Dr. Inge Winter Condition: Schizophrenia
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Phase 4 Schizophrenia Trial, Recruiting

NCT05958875
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:

  • People aged 18 to 70 years old, whether currently in hospital or being treated as an outpatient.
  • People who are willing and able to sign a consent form before any part of the study begins (a legal guardian may co-sign if needed).
  • Women who could become pregnant must use effective contraception throughout the trial and must have a negative pregnancy test before being enrolled.
  • People who have a confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, based on recognised diagnostic standards (DSM-5), confirmed by a structured interview.
  • People whose current psychiatric medication has not been working well enough — confirmed by a clinician's rating — and where that medication was taken for at least 4 weeks at an appropriate dose (other treatment lines are also accepted).
  • People whose treating doctor agrees that a change in psychiatric medication is needed.
  • People with at least a moderate level of symptoms, measured by specific psychiatric rating scales, and who are experiencing difficulties with daily functioning.

Who may not be able to join:

  • People who are currently pregnant or breastfeeding.
  • People who have previously used the medication clozapine.
  • People who have a known intolerance to clozapine and also to all other standard medication options being considered in the trial.
  • People who have medical reasons that rule out the use of clozapine and also all other standard medication options in the trial.
  • People who have taken part in another clinical trial involving an experimental drug or treatment within the 30 days before the first visit.
  • People who have another significant illness or condition that, in the investigator's opinion, could put them at risk or affect their ability to take part in the trial.
  • People who are experiencing active thoughts of suicide with some intention to act on them, where a treating clinician determines it would not be safe for that person to participate.
  • People who currently meet the criteria for a significant substance use disorder — severe alcohol or cannabis use disorder is not permitted, though nicotine dependence and mild-to-moderate alcohol or cannabis use disorder are allowed (confirm with trial site).
  • People who have been placed in a psychiatric or medical institution by a court or government authority.
  • People whose symptoms are already considered to be in remission, based on a specific set of clinical criteria.
  • People who have significant abnormal results on blood tests (particularly white blood cell counts or liver function), heart trace (ECG), or physical examination.
  • People who have a close dependent relationship with the trial sponsor, investigator, or 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 19 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

Phone: +31875553227

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
Dr. Inge Winter
Registry
ClinicalTrials.gov
Start date
1 August 2024
Est. completion
30 June 2028

Where this trial is recruiting

🇦🇹 Austria 🇩🇪 Germany 🇮🇹 Italy 🇪🇸 Spain 🇬🇧 United Kingdom

Primary endpoints

Change in symptom severity on Positive and Negative Syndrome Scale

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: 19 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