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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01043458
Eligibility Criteria:
Inclusion Criteria:
* Subject has signed informed consent;
* Current diagnosis of schizophrenia;
* Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
* Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
* Females are not pregnant, not breast-feeding;
* Females are post-menopausal or surgically sterile or practicing birth control;
* Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control
Exclusion Criteria:
* Diagnosis of schizoaffective disorder;
* Diagnosis with mental retardation;
* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
* Acute psychosis hospitalization within past 6 months;
* Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
* Current clozapine treatment;
* Suicidal ideation or behavior;
* BMI of 39 or greater;
* Relevant drug sensitivity or allergy;
* Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;
* Recent clinically significant illness/infection or surgery;
* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01043458
Study Brief:
Protocol Section:
NCT01043458