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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT00086320
Eligibility Criteria:
Inclusion Criteria:
* DSM-IV diagnosis of schizophrenia at least 1 year before screening
* experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120
* agree to be hospitalized for a minimum of 14 days at the start of the study
* capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
* resided at the same address continuously for at least 30 days prior to screening
* able and willing to fill out self administered questionnaires
* washout of antiparkinsonian medications, beta-blockers
* antiepileptics, lithium 3 days prior to the start of the run-in phase
Exclusion Criteria:
* DSM-IV Axis I diagnosis other than schizophrenia
* DSM-IV diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
* preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
* injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
* previous history of lack of response to risperidone when acutely psychotic
* history of neuroleptic malignant syndrome
* significant risk of suicidal or violent behavior
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00086320
Study Brief:
Protocol Section:
NCT00086320