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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT00934635
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
* Patients with a specified severity of the disease (Clinical Global Impression Scale of Severity (CGI-S) range of \> 2 \< 5)
* Patients must be on antipsychotic medication with either paliperidone ER or oral risperidone in monotherapy for at least two weeks and must be at least five days on a stable dose of either paliperidone ER 6 mg or 9 mg or oral risperidone 4 mg or 6 mg once daily
* Female patients of childbearing potential must have a negative human chorionic gonadotropin urine pregnancy test (ß-HCG) at visit 1 or must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry, throughout the study and at least one month after study end
* Healthy control volunteers must be off all standard prescription drug therapy, over the counter compounds (OTC) and recreational substances/drugs for at least one week prior to participation in the study
* Female volunteers of childbearing potential must have a negative ß -HCG pregnancy test at visit 1 or be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry, throughout the study and at least one month after the study end
* Patients and volunteers must be able to read, understand and sign the Institutional Review Board approved informed consent form
Exclusion Criteria:
* Patients: Any depot neuroleptic medication (long acting injectables) in the last three months
* Any antipsychotic compound, antidepressant, antiepileptic ("mood stabilizers"), lithium, anticholinergic within 2 weeks prior to study
* Any psychopharmacologically active medication (except benzodiazepines, paracetamol and zopiclone as rescue medication) taken within the trial
* Physical and psychological conditions that interfere with the study procedures, or could influence the study results, or could endanger the patient during the study
* Alcohol and/or drug abuse four weeks prior to study start (patients with alcohol or drug abuse as defined by the DSM-IV criteria can participate if free of their of abuse for at least four weeks)
* Clinically relevant laboratory abnormality
* Pregnant or breast feeding patients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00934635
Study Brief:
Protocol Section:
NCT00934635