drugset / Trial / NCT02237417
Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-09-01
- Primary completion
- 2018-11-30
- Completion
- 2020-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | 400 mg | Oral |
| Comparator | Lurasidone | Small molecule | — | Oral |
| Comparator | Olanzapine | Small molecule | — | Oral |
| Comparator | Quetiapine | Small molecule | — | Oral |
| Comparator | Risperidone | Other / unclassified | — | Oral |
| Comparator | Ziprasidone | Small molecule | — | Oral |