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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT01724359
Eligibility Criteria:
Inclusion Criteria:
* Patient meets the criteria for schizophrenia
* Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
* Patient is healthy on the basis of a physical examination and vital signs at screening
* Women 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 and throughout the study
Exclusion Criteria:
* Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
* Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
* Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
* Patients judged to be at high risk for adverse events, violence, or self-harm
* Patients with known hypersensitivity to paliperidone ER or to risperidone
* Patients with a current use or known history (over the past 6 months) of substance dependence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01724359
Study Brief:
Protocol Section:
NCT01724359