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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT01503359
Eligibility Criteria:
Inclusion Criteria:
\- Diagnosis of schizophrenia (ICD-10)
Other criteria related to the diagnosis verified during the selection visit:
* The score for the PANSS negative symptoms subscale ≥ 21,
* Severity of individual symptoms in the PANSS positive symptoms subscale may not exceed 3 points.
Exclusion Criteria:
General
* lack of written informed consent,
* risk of noncompliance during the study period,
* patients who can not be assessed throughout the study period (eg. due to travel or vacations),
* pregnancy or breastfeeding,
* women of childbearing potential not using effective contraception (ie. birth control pill, surgical sterilization, hormonal contraceptive injection, IUD, contraceptive implant, patch, or condoms),
* participation in another clinical study, currently or within 3 months before the visit of a selection panel
* patients previously subjected to selection for this study.
Medical and Therapeutic Criteria Associated with schizophrenia
* patients in acute psychosis, severe symptoms of productive,
* patients taking clozapine,
* declaring suicidal tendencies, history of committing suicide in the past year.
Associated with other psychiatric disorders
* patients currently meeting criteria for ICD-10 diagnosis of mental disorder other than schizophrenia (in the last 6 months before the visit of a selection), confirmed by the MINI questionnaire
* patients showing a prevalent and / or severe symptoms of depression (even without meeting criteria for major depressive episode according to ICD-10 criteria),
* patients ever diagnosed with lifetime bipolar disorder,
* patients with severe personality disorders, particularly type of antisocial, borderline, or histrionicznego that could affect the assessment of test results.
Other
* abuse or addiction to alcohol or psychoactive substances (excluding nicotine) within the last 6 months, according to the criteria of ICD-10, confirmed by the MINI questionnaire,
* disturbances occurring in the form of somatic according to ICD-10 criteria,
* Delirium or dementia according to ICD-10 criteria,
* current diagnosis of neurological diseases (eg, stroke, seizures, migraine, multiple sclerosis),
* liver failure (ie, cirrhosis or active liver disease), diagnosed acute or chronic hepatitis,
* severe or uncontrolled somatic disease that could affect the course of the study (eg cancer, cardiovascular, respiratory, metabolic or oral, severe renal failure, unstable diabetes type I or II, morbid obesity, untreated or uncontrolled hypertension, clinically significant blood),
* thyroid dysfunction (especially hypothyroidism) untreated or uncontrolled, T - thyroid hormones treatment started, terminated or modified in the 3 months before the selection visit,
* hormone replacement therapy started, terminated or modified in the 3 months before the selection visit.
* recognized disorders of hemostasis,
Associated with a prior or concomitant treatment Particular caution should be maintained when using drugs likely to affect the central nervous system - their mechanism of action could affect the course of the study. Use of these substances after the selection visit is not allowed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01503359
Study Brief:
Protocol Section:
NCT01503359