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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01626456
Eligibility Criteria:
Inclusion Criteria:
(Subjects who participated in ALK9072-003)
* Completed the ALK9072-003 Day 85 visit
* Continues to require treatment with an antipsychotic medication
(New Subjects)
* On a stable dose of oral antipsychotic medication
* Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
* Has been able to achieve outpatient status for more than 3 months prior to screening
* Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation
Exclusion Criteria:
(Subjects who participated in ALK9072-003)
* Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
* Missed more than 1 scheduled study visit during participation in study ALK9072-003
* Has a significant or unstable medical condition that would preclude safe completion of the current study
* Subject is pregnant or breastfeeding
* Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures
(New Subjects)
* History of poor or inadequate clinical response to treatment with aripiprazole
* History of treatment resistance
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
* Currently under involuntary hospitalization
* Current or expected incarceration
Additional inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01626456
Study Brief:
Protocol Section:
NCT01626456