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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT00888693
Eligibility Criteria:
Inclusion Criteria:
* Subject has signed informed consent;
* Current DSM-IV-TR diagnosis of schizophrenia;
* Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
* Meets study-specific PANSS criteria;
* Willing and able to cooperate with cognitive testing
* 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:
* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
* Diagnosis of schizoaffective disorder;
* Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
* Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
* Current clozapine treatment; suicidal ideation or behavior;
* BMI of 39 or greater; current homicidal or violent ideation;
* Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
* Positive hepatitis or HIV test result;
* Recent clinically significant illness/infection or surgery;
* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
* Visual, hearing or communication disability
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00888693
Study Brief:
Protocol Section:
NCT00888693