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 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 12:46 AM
NCT ID:
NCT00810667
Eligibility Criteria:
Inclusion Criteria:
* Primary diagnosis of schizophrenia
* Man or woman, aged between 18-65
* Patient is on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening
* The patient has a PANSS total score between 70 and 100 (extremes included) at screening
Exclusion Criteria:
* Primary psychiatric diagnosis other than schizophrenia
* Acute exacerbation requiring hospitalisation within the last 3 months
* Clinically significant extrapyramidal symptoms
* Clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
* Significant ECG abnormalities
* In concurrent treatment with drugs inhibiting the P450 enzymes system CYP2D6 and other CYP Isozymes
* Failed to respond to adequate courses of treatment with risperidone
* Treated with an antipsychotic other than risperidone within 4 weeks prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00810667
Study Brief:
Protocol Section:
NCT00810667