At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open Label, Parallel Group, Study of the Impact of Aripiprazole (Abilify®) Once Monthly Versus Standard of Care Oral Antipsychotic Medications on Changes in Brain Structure and Metabolism
In Brief
A Phase 4 clinical trial evaluating Standard of Care Oral antipsychotics, IM aripiprazole once monthly, and 1 other intervention for Schizophrenia. Completed, enrolled 47 participants across 1 site.
Detailed Summary
This is a Phase 4, randomized, open-label, parallel group study designed to assess the clinical and biological effects of 12 months of treatment with long acting intramuscular (IM) aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral antipsychotic medications and compared with a healthy control group.
Study Details
Timeline
Interventions
A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.
A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.
A total of 15 healthy controls will participate in the study and will not receive medication