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:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT00645502
Eligibility Criteria:
Inclusion Criteria:
* Patients with diagnosis of schizophrenia of any subtype
* who have a normal weight as defined by Body Mass Index in range of 18.0 to 35.0, extremes included
* For whom an Informed consent form signed by the patient or legally acceptable representative is available and who are healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram (ECG), and the results of blood biochemistry and hematology tests and a urinalysis carried out less than 3 weeks before the first dose of study medication is taken
Exclusion Criteria:
* Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV
* Patients who received oral risperidone or paliperidone within 14 days of first drug administration, Risperdal Consta within 100 days of first drug administration or paliperidone palmitate within 10 months of first drug administration
* Patients who used medication known to be an hepatic enzyme inducer or inhibitor less than 2 weeks prior to first drug administration
* Patients with history of allergic reaction to risperidone or its excipients
* Patients with diagnosis of alcohol or substance abuse
* Patients with history of clinically relevant cardiac arrhythmia's, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, parkinsonism, or drug allergy
* Female patients who are pregnant or are breastfeeding or are of childbearing potential without adequate contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00645502
Study Brief:
Protocol Section:
NCT00645502