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

PHASE4CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

September 1, 2014

Primary Completion Date

November 30, 2018

Study Completion Date

July 30, 2020

Conditions
Schizophrenia
Interventions
DRUG

Standard of Care Oral antipsychotics

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.

DRUG

IM aripiprazole once monthly

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.

OTHER

No Treatment

A total of 15 healthy controls will participate in the study and will not receive medication

Trial Locations (1)

84108

University of Utah, Salt Lake City

Sponsors
All Listed Sponsors
collaborator

Otsuka America Pharmaceutical

INDUSTRY

lead

University of Utah

OTHER