Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism

Phase 4

Completed

Interventions: Other: No Treatment
Drug: Standard of Care Oral antipsychotics
Drug: IM aripiprazole once monthly

Brief 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.

Detailed Description: 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.

It is hypothesized that improved treatment compliance will lead to fewer white matter changes in the brain. Fewer white matter changes will be demonstrated via neuroimaging as increased FA and BPF values in the prefrontal region, and an increase in metabolites in a voxel centered on the anterior cingulate cortex (ACC) as seen with MRS. Therefore, the aim of this study is to examine the structural and metabolic effects of aripiprazole (Abilify®) once monthly in patients with schizophrenia using MRI techniques and to examine these effects in association with cognitive and clinical measures.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Healthy Control	No Treatment	Healthy individuals with no mental health diagnosis
Individuals with Schizophrenia (Group A)	Standard of Care Oral antipsychotics	Individuals with a diagnosis of Schizophrenia undergoing standard of care treatments.
Individuals with Schizophrenia (Group B)	IM aripiprazole once monthly	Individuals with Schizophrenia who are receiving treatment with Aripiprazole once monthly injections.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Changes in Fractional Anisotropy (FA)	12 months	To determine if there are differences in prefrontal white matter fractional anisotropy (FA) in subjects with schizophrenia from baseline at 12 months of treatment with aripiprazole (Abilify®) once monthly compared with standard of care (SOC) oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI (Geodon®)).

Secondary Outcome Measures