Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkermes, Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
(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
You may not be if
(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
Clareo Health | A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)