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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01412060
Eligibility Criteria:
Inclusion Criteria:
* Participants who have provided informed consent prior to any study specific procedures.
* Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
* Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
* Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
* Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
* Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
* Body mass index between 18 and 40 kg/m\^2, inclusive.
Exclusion Criteria:
* Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
* Participants in their first episode of psychosis.
* Treatment-resistant schizophrenia over the last 2 years.
* Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
* At imminent risk of injuring self or others or causing significant damage to property.
* Suicide risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01412060
Study Brief:
Protocol Section:
NCT01412060