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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT02624167
Eligibility Criteria:
Inclusion Criteria:
1. Male/female; if female, must not of childbearing potential
2. 18 to 65 years of age, inclusive;
3. Has a current diagnosis of schizophrenia
4. Has a total score on the PANSS \< 75.
5. Positive symptoms sub-scale score not to exceed 15; score of ≥4 on no more than 2 positive symptoms
6. Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly to moderately severely ill.
7. Is in need of anti-psychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening of oral risperidone or aripiprazole (at least 2 mg risperidone dose-equivalent).
8. Current symptoms present for at least one month.
9. Patient agrees to be hospitalized for up to 2 days at the start of dosing and at each dose increase
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02624167
Study Brief:
Protocol Section:
NCT02624167