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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02694328
Eligibility Criteria:
Inclusion Criteria:
* Subject has a body mass index (BMI) of 18.0-30.0 kg/m\^2, inclusive, at Visit 1 and Visit 2
* Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
* Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
* Subject has maintained a stable body weight (change \</= 5%) for at least 3 months prior to Visit 1 based on self-report
* Additional criteria may apply
Exclusion Criteria:
* Subject has any of the following psychiatric conditions per DSM-5 criteria:
* Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
* Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
* Drug-induced or toxic psychosis
* Any other psychiatric condition that could interfere with participation in the study
* Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
* Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
* Additional criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02694328
Study Brief:
Protocol Section:
NCT02694328