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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT04959032
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 to 60 years of age, inclusive.
* Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM-5 (modified SCID-5).
* Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.
* Current psychotic episode \< 4 weeks duration at Visit 1.
* PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.
* Rating of at least 4 (moderate) on at least two of the following four PANSS positive symptoms: delusions (P1), hallucinatory behavior (P3), conceptual disorganization (P2), suspiciousness/persecution (P6) at Visit 1 and Visit 2.
* Patient must identify a caregiver who provides consents to participate in the study.
* In the opinion of the Investigator, the patient has significant risk for suicidal behavior during the course of his/her participation in the study.
Exclusion Criteria:
* Currently meeting DSM-5 criteria for any of the following:
Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders; Bipolar I or Bipolar II Disorder; Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; Known or suspected borderline or antisocial personality disorder or other DSM 5 personality disorder of sufficient severity to interfere with participation in this study; Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study.
* Patients in their first episode of psychosis.
* Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04959032
Study Brief:
Protocol Section:
NCT04959032