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:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT02002832
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent and aged between 18 and 65 years of age.
* Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
* Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
* Able and agrees to remain off prior antipsychotic medication for the duration of study.
* Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Exclusion Criteria:
* Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
* Any chronic organic disease of the CNS(other than schizophrenia)
* Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02002832
Study Brief:
Protocol Section:
NCT02002832