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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT00712660
Eligibility Criteria:
Inclusion Criteria:
1. Men and women, ages 18 to 60 years, inclusive. Earliest inclusion day is the 18th birthday and the latest is the day before the 61st birthday.
2. A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
3. Increased risk for relapse, defined as having at least 1 psychiatric hospitalization for psychosis within the past 3 years and at least 2 psychiatric hospitalizations for psychosis in total (i.e. ≥ 2 hospitalizations).
4. Clinical Global Impression scale - Severity (CGI-S) ≤ 3 at study Visit 1.
5. All patients must be on stable doses of antipsychotic medication during the study entry.
6. Absence of organic mental disorder, mental disorder due to psychoactive substance use or mental retardation.
7. Presence of a cooperating family member, caregiver or other person who is in frequent contact with the patient (at least 4 times a week) and who is willing to participate in the trial.
8. Signed written informed consent. The informed consent process must be documented by signing the informed consent form prior to any study-related procedures.
9. Eligibility for mobile phone communicating.
Exclusion Criteria:
1. Participation in another relapse prevention program or another interventional clinical trial will be prohibited during the entire participation in the study. Subjects enrolled in observational (non-interventional) trials are not excluded from this study.
2. Hayward compliance rating scale score \< 2 at Visit 1.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00712660
Study Brief:
Protocol Section:
NCT00712660