Phase 3 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 were aged 18 to 65 years old at the time they were enrolled in the earlier related study (KAR-012).
• People who successfully completed the full treatment period of the earlier study, KAR-012.
• People who, in the doctor's opinion, followed all the procedures required in study KAR-012.
• People who, in the doctor's opinion, consistently took their background antipsychotic medication as required during study KAR-012 (the same medication and dose would need to continue throughout this new study).
• People who are able and willing to sign a consent form before any study activities begin.
• People who, in the doctor's opinion, have a stable living situation.
• People who have a reliable support person (such as a family member or carer) who is willing and able to help with study activities when needed. In Bulgaria, this person must be present in person at appointments where the doctor feels their input is needed.
• Women who could become pregnant, or men whose partners could become pregnant, must be willing to use at least one highly effective form of contraception throughout the study and for at least 30 days after the last dose of the study drug. Sperm donation is also not permitted for 30 days after the final dose.

Who may not be able to join:

• People who, based on a doctor's clinical assessment or a standardised suicide risk questionnaire (called the C-SSRS), show signs of active thoughts of suicide with any intention to act on them.
• People who had any clinically significant abnormal results from heart (ECG) tests, blood tests, physical examination, or vital signs at the end of study KAR-012, which the doctor and medical team consider could affect safety.
• Women who are pregnant.
• People who, in the doctor's opinion (or the study sponsor's medical team's opinion), are not suitable for the study for any reason, or where any finding may affect their safety or their ability to follow the study schedule.
• People considered to be at risk of violent or destructive behaviour, as judged by the doctor.
• People currently taking part in, or planning to take part in, another clinical trial during this study.
• People with a history of, or high risk of, urinary retention (difficulty emptying the bladder), stomach/gut retention, or a specific type of eye pressure condition called narrow-angle glaucoma, as assessed by the doctor.
• People who are currently taking, or plan to take, any medications that are not permitted alongside this study drug.
• For male participants only, people who have any of the following: a history of bladder stones; a history of recurring urinary tract infections; a specific prostate blood test result (PSA) above 10 ng/mL; certain high scores on a standardised prostate symptom questionnaire (IPSS) (confirm with trial site for exact score thresholds). Note: the prostate-related assessments are required only for male participants aged 45 and over.

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