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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00361166
Eligibility Criteria:
Inclusion Criteria:
* male or female subjects ages 18-65 diagnosed with schizophrenia
* experiencing an acute exacerbation of psychosis
* has had prior response to antipsychotic therapy within the previous 3 years
* female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception
* ability of subject or caregiver or legally authorized representative to provide informed consent
* subjects must be hospitalized at screening and must be willing to remain in the hospital at least 14 days after baseline and must comply with all study events through completion of the study
Exclusion Criteria:
* inability of the subject or caregiver or legally authorized representative to provide consent
* any female subject who is pregnant or breast feeding
* any subject with concurrent mental illness or disability
* any subject considered to be a danger to themselves or others
* recent use of certain antipsychotics or other medications that might interfere with this study's medication
* abnormal clinical laboratory values
* presence, or recent history, of serious medical conditions or drug abuse
* likely allergy or sensitivity to ACP-103, haloperidol, or risperidone, based on known allergies to drugs of the same class
* any subject who has participated in a prior clinical trial of ACP-103
* any subject judged by the Principal Investigator to be inappropriate for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00361166
Study Brief:
Protocol Section:
NCT00361166