Phase 2 Schizophrenia Trial, Recruiting

Written by an AI model from the 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 aged 18 to 50 years old at the time of screening
• People who are able to understand the study procedures and agree to take part voluntarily
• People who have been diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder
• People who are not currently taking any antipsychotic medication (by their own choice and for reasons unrelated to this study), and who have been off antipsychotics for at least 3 weeks (or at least 4 weeks for certain specific medications, including aripiprazole or long-acting injectable antipsychotics) by the time of the baseline brain scan
• People whose symptom severity scores fall within a specific range on a standard psychiatric assessment tool (confirm with trial site)
• Women who could become pregnant and are willing to use approved birth control methods for the full duration of the study
• People who have been taking herbal or dietary supplements at a steady dose for at least 6 weeks before the first study medication dose, and who are willing to avoid certain supplements known to affect the liver (such as green tea extract, kratom, and ashwagandha)

Who may not be able to join:

• People who have had a moderate or severe problem with substance use within the past month before their first brain scan
• People who have previously responded poorly to, or had an allergic reaction to, the study drug (Cobenfy) or a related medicine called trospium, or who have taken Cobenfy within 4 weeks of the first brain scan
• People whose heart electrical activity reading (ECG) shows a certain abnormality, specifically a measurement called QT interval that is too long (above 450 milliseconds for men, or above 470 milliseconds for women)
• Women who are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy blood test at their first visit, must have been using an approved method of birth control for 30 days before the study, and must continue doing so throughout the study and for 30 days after it ends (unless they have been through menopause or have had a surgical procedure that prevents pregnancy)
• People with certain serious or unstable health conditions that could affect their safety on the study medication — this includes (but is not limited to) difficulty emptying the bladder, significant liver problems, difficulty emptying the stomach, untreated certain types of glaucoma, a resting heart rate above 100 beats per minute, high blood pressure above a certain level, a history of sudden blood pressure drops when standing up, HIV (by self-reported history), liver cirrhosis, certain bile duct or liver conditions, active liver infection, a history of bladder stones, frequent urinary tract infections, or significant urinary symptoms in men (confirm with trial site for full details)
• People who have metal objects inside their body that are not safe for MRI scans, or who have had certain nuclear medicine imaging procedures in the past year that, when combined with the radiation from this study's brain scans, would exceed safety limits set by the FDA
• People who have had thoughts of suicide with a plan or intent in the past month, or who have made a suicide attempt in the past 3 months
• People whose blood test results show certain abnormalities, including liver enzyme levels more than twice the normal range, elevated bilirubin levels, or, for men, a prostate-specific antigen (PSA) level above 10 ng/ml
• People who have a history of not responding to antipsychotic medications
• People who have used any nicotine products in the month before their first brain scan
• People with a history of serious violent behaviour when not on antipsychotic medication, or who are currently having thoughts of harming others
• People whose urine or blood drug screen comes back positive for substances of abuse

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