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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03629951
Eligibility Criteria:
Inclusion Criteria:
* Participants and their legally acceptable representative where applicable must be able to sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate for the duration of the study
* Have a clinical diagnosis of schizophrenia made by a clinician with understanding of the criteria for schizophrenia or schizoaffective disorder, per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5), and had at least 1 relapse, in the opinion of the investigator, within the last 12 months prior to date of informed consent
* Must be receiving an OAP treatment regimen at the time of enrollment
* Must be able to speak, read, and understand English and/or the local Indian language as the patient reported outcome instruments will be validated in regional languages
* Caregivers/Informants should be able to sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate for the duration of the study
Exclusion Criteria:
* Has treatment resistant schizophrenia (that is, currently receiving clozapine or electroconvulsive therapy \[ECT\])
* Is on long-acting injectable antipsychotic regimen at the time of screening
* Has a moderate to severe substance use disorder (other than nicotine), as determined by the investigator
* Has a significant risk of suicide or active suicidality with a plan as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment
* Has an immediate need for hospitalization (that is, the participant is already in a relapse)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03629951
Study Brief:
Protocol Section:
NCT03629951