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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00621634
Eligibility Criteria:
Inclusion Criteria:
* chronic schizophrenia patients under long-term antipsychotic drug treatment, stable for at least 3 months before study entry;
* presence of tardive dyskinesia following Schooler-Kane research criteria (mild intensity (2/4 points) in at least two body segments, or moderate intensity (3∕4 points) for at least one body segment);
* patients capable to understand the goals and procedures of the study, and to provide informed consent;
* women of childbearing age will be requested to use an effective contraceptive method throughout the study.
Exclusion Criteria:
* subjects with medical conditions susceptible to significantly increase the risk of adverse effects, or to interfere with the conduct of the study; in particular, those with a history of coronary artery disease, pancreatitis, diabetes, coagulation disorders, or hemorrhagic conditions;
* those regularly taking aspirin, anticoagulants, or oral lipid-lowering agents;
* those with fasting baseline triglyceride values \>4.0 mmol/L, or with cholesterol values \>8 mmol/L ;
* those intolerant or allergic to fish, seafood, or any other substance contained in the study medication or matching placebo;
* those who have abused illegal street drugs during the past year;
* those unlikely to comply with the study requirements;
* those who consume natural health products of marine or vegetable source, containing omega-3 essential fatty acids;
* women who are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT00621634
Study Brief:
Protocol Section:
NCT00621634