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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT00828958
Eligibility Criteria:
Inclusion Criteria:
* Chronic schizophrenia of any subtype, according to DSM-IV criteria
* under current treatment with long-acting injectable risperidone 25 mg or 37.5 mg gluteal injections in an adequate study for at least 2 injections, and in need of a dose increase of long-acting injectable risperidone for clinical reason
* informed consent signed by the patient
* patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
Exclusion Criteria:
* No DSM IV Axis I diagnosis other than schizophrenia
* no pregnant or breast feeding women
* no female subject of childbearing potential without adequate contraception
* no history of severe drug allergy or hypersensitivity
* no patients with inadequate mass in the deltoid regions to receive the intramuscular drug injections.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00828958
Study Brief:
Protocol Section:
NCT00828958