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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT01527305
Eligibility Criteria:
Inclusion Criteria:
* Have a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
* Must be admitted to a hospital within 4 weeks prior to Screening experiencing an acute exacerbation of schizophrenia
* Have a positive and negative syndrome scale (PANSS) total score of more than or equal to 60 or clinical global impressions - severity (CGI-S) score of more than or equal to 4 (moderately ill) at Screening
* Agree to protocol-defined method of contraception
* Must be medically stable based on physical examination, medical history, vital signs, and clinical laboratory tests performed at Screening
Exclusion Criteria:
* Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
* Have evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in medical history, clinical laboratory or physical examination
* Have a history of neuroleptic malignant syndrome
* Participants at risk of suicide
* Have received clozapine within 1 month prior to Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01527305
Study Brief:
Protocol Section:
NCT01527305