Phase 3 Schizophrenia Trial, Recruiting NCT07184619 Sponsor: Newron Pharmaceuticals SPA Condition: Schizophrenia
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Phase 3 Schizophrenia Trial, Recruiting

NCT07184619
Recruiting Phase 3

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 are 18 years old or older.
  • If you are female, you have a negative pregnancy test at the start of the study, are not breastfeeding, and agree to use appropriate birth control (unless you cannot become pregnant).
  • You have been diagnosed with schizophrenia according to current medical guidelines (DSM-5-TR).
  • Your schizophrenia has not responded well enough to antipsychotic medications, meeting a specific definition of treatment-resistance (confirm with trial site).
  • You are currently taking one or more antipsychotic medications at a recommended therapeutic dose as part of your regular care.
  • Your illness is rated at least "mildly ill" or worse on a standard medical assessment scale at the start of the study.
  • Your symptom scores on standard psychiatric rating scales (BPRS and PANSS) are above certain set thresholds at the start of the study (confirm with trial site).
  • Your overall daily functioning is significantly impaired, as measured by a standard scale (confirm with trial site).
  • You are consistently taking your prescribed antipsychotic medication as directed.
  • You have given your written agreement to take part in the study before it begins.

Who may not be able to join:

  • You have a diagnosis of a related but different condition, such as schizophreniform disorder, schizoaffective disorder, bipolar disorder, or major depressive disorder.
  • You have been diagnosed with a substance use disorder in the past three months, or currently have one.
  • Your current symptoms are so severe that you need to be hospitalised to stabilise them — unless your medication dose has been stable for at least 6 weeks before the study screening.
  • You have a history of, or are currently diagnosed with, other psychiatric or behavioural disorders.
  • You are considered to be at known risk of suicide, or you have made a suicide attempt in the past 2 years.
  • You have a history of a serious reaction to antipsychotic medication called neuroleptic malignant syndrome, or a condition called priapism.
  • You have any other health condition that could affect your safety or interfere with the study results (confirm with trial site).
  • You have a history of epilepsy or seizures, have had a seizure in the past year, or have had repeated seizures caused by drugs.

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 16 July 2026
Phase 3: approximately ~65% 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: Ravi Anand, MD, Newron Pharmaceuticals

Phone: +39 02 610 3461

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 3
Sponsor
Newron Pharmaceuticals SPA
Registry
ClinicalTrials.gov
Start date
23 January 2026
Est. completion
31 December 2026

Where this trial is recruiting

🇮🇳 India 🇺🇸 United States

Primary endpoints

Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).; Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).

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: 16 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