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 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT01323205
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive
* Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests
* In- or outpatients who have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) at least 1 year prior to screening.
Exclusion Criteria:
* A current DSM-IV axis I diagnosis other than schizophrenia
* Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
* Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases
* PANSS score \<50 or \>120
* Other significant and/or unstable systemic illnesses
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01323205
Study Brief:
Protocol Section:
NCT01323205