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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT01377233
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)
* A score of \<=4 (moderately ill) on Clinical Global Impression - Severity of Illness (CGI-S) scale
* A total score \>=60 on Positive and Negative Syndrome Scale (PANSS)
* A score of \<=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)
Exclusion Criteria:
* Acute exacerbation requiring hospitalization within the last 3 months OR requiring change of antipsychotic medication within the last 4 weeks
* Diagnosis or history of substance dependence or substance abuse according to DSM-IV-TR within the last 3 months
* Significant risk of harming himself/herself or others
* Positive serology for hepatitis A, B, C, or HIV
* Present condition that might compromise liver function
* Medical or neurological disorder or treatment that could interfere with study treatment or compliance
* Previous exposure to zicronapine
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01377233
Study Brief:
Protocol Section:
NCT01377233