Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT01081769
Eligibility Criteria:
Inclusion Criteria:
* Have been meeting the diagnostic criteria for schizophrenia for 1 to 5 years before screening, and have a history of treatment with antipsychotics
* Have a history of two or more relapses requiring psychiatric hospitalization in the preceding 24 months, which may include the current acute episode
* Experiencing at screening an acute schizophrenic episode with a Positive And Negative Syndrome Scale (PANSS) total score at screening between 70 and 120, inclusive
* Be healthy on the basis of physical examination, medical history and vital signs performed at screening
* Woman must be postmenopausal (for at least 1 year) or surgically sterile or abstinent or be practicing an effective method of birth control, must agree to continue to use the same method of contraception throughout the study and must have a negative urine pregnancy test at screening
* be able to fill out questionnaires
* Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
Exclusion Criteria:
* Patients that have never been treated with antipsychotics before
* Treatment resistant patient and/or currently (i.within the last 3 months) treated with clozapine
* Substance dependence within 6 months prior to entry and current intravenous drug use or abuse
* allergies, hypersensitivity, or intolerance to risperidone or paliperidone or excipients
* treatment with a long-acting injectable antipsychotic within three injection cycles prior to screening
* newly started psychotherapy program within the two months preceding the treatment phase baseline
* evidence of clinically significant hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances in the past 6 months (as determined by medical history, clinical laboratory or ECG results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study
* history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
* involuntarily hospitalized patient
* pregnant or breast-feeding females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01081769
Study Brief:
Protocol Section:
NCT01081769