Phase 3 Schizophrenia Trial, Recruiting
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.
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
Where this trial is recruiting
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?
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.