Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are between 22 and 70 years old (men and women who are not pregnant)
• People who have been formally diagnosed with schizophrenia as their primary condition, confirmed through a structured diagnostic interview
• People who are generally in good physical health, without any serious active medical problems
• People whose schizophrenia has not responded to treatment, specifically those who have tried at least two different antipsychotic medications from two different drug families, and have also tried either electroconvulsive therapy (ECT) or the medication clozapine, without lasting improvement
• People who are currently experiencing ongoing and distressing psychotic symptoms
• People whose symptoms score at or above 90 on a standard psychiatric rating scale (called the PANSS) on two separate assessments taken about one month apart
• People whose PANSS positive symptom score includes at least one item rated 5 or higher (on a scale where higher numbers indicate more severe symptoms)
• People who have had a normal brain MRI within 3 months before surgery
• People who have been on a stable antipsychotic medication plan for at least one month before surgery
• People who have had a normal thyroid hormone (TSH) blood test within 12 months of joining the study
• People whose other medical conditions have been stable for at least 6 months
• People who are willing and able to give informed consent and attend regular clinic visits for at least 12 months after surgery
• People who have a treating psychiatrist or a close family member available to take part in discussions about the study and co-sign the consent form
• People who are willing to sign a treatment agreement with the trial
• People who have family or caregiver support available throughout the study will be given preference for inclusion
• Women of childbearing potential who are able to provide a negative pregnancy blood test at screening and at additional points during the study, agree to use highly effective contraception throughout the study, and can confirm a menstrual period before beginning
• Men who are able and willing to use highly effective contraception throughout the study

Who may not be able to join:

• People who have had an active alcohol or drug use disorder in the past 6 months (not including nicotine), or who test positive for illegal drugs on a urine test
• People who are currently at significant risk of suicide, including those with a plan or clear intent to harm themselves, or who have made a suicide attempt in the past year
• People who have a neurological or medical condition that the surgeon considers would make surgery too risky (for example, a progressive brain disease, a significant heart or lung condition, or a need for ongoing blood-thinning medication)
• People with a history of seizures, bleeding stroke, or factors that increase seizure risk — such as a brain injury, a developmental brain condition, a congenital brain abnormality, or current use of medications known to lower the seizure threshold
• People with a medical reason that would make surgery unsafe, such as an active infection
• People with blood clotting problems, including certain abnormal results on blood clotting tests or a low platelet count
• People with uncontrolled high blood pressure (readings consistently above 140/90 mmHg on three repeated measurements within one hour, regardless of whether blood pressure medication is being taken)
• People with a specific abnormal heart electrical reading (QTc interval greater than 450 milliseconds)
• People who have taken part in another drug, device, or biological research study within the past 90 days
• People who currently have an implanted electrical device such as a pacemaker, defibrillator, or any type of nerve or spinal stimulator
• People who require a type of heat-based medical treatment called diathermy
• People who take blood-thinning or anti-clotting medications that cannot be safely stopped for at least 2.5 weeks around the time of surgery
• People who have any psychiatric, neurological, or medical condition that the study investigator considers makes them unsuitable for the study
• Women of childbearing potential who are unwilling or unable to use highly effective contraception throughout the study
• Women of childbearing potential who are unwilling or unable to provide a negative pregnancy blood test at screening and at required points during the study
• People with a heart condition that the study doctor believes would make general anaesthesia or the study medication (ketamine) too risky
• People with poorly controlled high blood pressure or a persistently fast heart rate at the start of the study
• People who are currently taking an antidepressant medication
• People with known reasons they cannot receive ketamine or esketamine, including:
  • People for whom a significant rise in blood pressure would be dangerous
  • People with a known allergy to ketamine, esketamine, or any of their ingredients
  • People with certain types of blood vessel disease, such as aortic aneurysm, arteriovenous malformation, or similar conditions
  • People with a history of bleeding in the brain
  • People with a resting heart rate above 90 or below 55 beats per minute
  • People taking certain medications known to interact with ketamine (confirm specific medications with the trial site)
  • People showing signs of central nervous system depression (such as reduced alertness or slow breathing) linked to sedating medications, or assessed as high risk using a specific risk scoring tool used by the study team
  • People who, on the day of planned ketamine administration, test positive on a urine drug screen for substances that could interact unsafely with ketamine

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