Trial Outcomes & Findings for Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism (NCT NCT02237417)
NCT ID: NCT02237417
Last Updated: 2025-03-14
Results Overview
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®)).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
47 participants
Primary outcome timeframe
12 months
Results posted on
2025-03-14
Participant Flow
Participant milestones
| Measure |
Healthy Control
No Treatment: A total of 15 healthy controls will participate in the study and will not receive medication
|
Individuals With Schizophrenia (Group A)
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.
|
Individuals With Schizophrenia (Group B)
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
16
|
|
Overall Study
COMPLETED
|
16
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism
Baseline characteristics by cohort
| Measure |
Healthy Control
n=16 Participants
No Treatment: A total of 15 healthy controls will participate in the study and will not receive medication
|
Individuals With Schizophrenia (Group A)
n=15 Participants
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.
|
Individuals With Schizophrenia (Group B)
n=16 Participants
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.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
28 years
n=5 Participants
|
30 years
n=7 Participants
|
28 years
n=5 Participants
|
28 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
16 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTo 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®)).
Outcome measures
| Measure |
Healthy Control
n=16 Participants
No Treatment: A total of 15 healthy controls will participate in the study and will not receive medication
|
Individuals With Schizophrenia (Group A)
n=15 Participants
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.
|
Individuals With Schizophrenia (Group B)
n=16 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Changes in Fractional Anisotropy (FA)
|
13 Participants
|
9 Participants
|
7 Participants
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individuals With Schizophrenia (Group A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Individuals With Schizophrenia (Group B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60