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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT00915512
Eligibility Criteria:
Inclusion Criteria:
* Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
* To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
* Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
* Participants who are willing and capable to complete the questionnaires
Exclusion Criteria:
* Use of clozapine, depot neuroleptics or risperidone within the last 3 months
* Any unstable clinical condition including clinically important abnormal laboratory findings
* Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
* History of malignant neuroleptic syndrome
* To be considered carrying high risk regarding adverse effects, homicide and/or suicide
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00915512
Study Brief:
Protocol Section:
NCT00915512