Schizophrenia Clinical Trial
Official title:
Aripiprazole, Abilify Maintena Collaborative Clinical Protocol
An Open-label, Multi-center, Longitudinal, Within-subject Comparison Study to Evaluate the Effects of Aripiprazole Once Monthly in Subjects with Schizophrenia on 30-, 90-, and 180- day Re-hospitalization Rates Following Hospital Discharge Compared with Retrospective Re-hospitalization Rates while on Oral Antipsychotic Medication.
This is an open-label, multi-center, longitudinal, within-subject comparison study of the
effects of aripiprazole once monthly on 30-, 90-, and 180-day psychiatric re-hospitalization
rates following hospital discharge in subjects with schizophrenia compared with prior
psychiatric hospitalization rates while on oral antipsychotics.
Prospective subjects will undergo screening for eligibility for entry into the study while
hospitalized for symptoms due to schizophrenia.
Prospective subjects will be hospitalized for the necessary length of time as determined by
the assigned treatment provider as clinically indicated, per the current standard of care. To
be eligible, the anticipated duration of hospitalization should be long enough to accommodate
the screening procedures, the 3-day Oral Tolerability Phase (if applicable), and initiation
of treatment with aripiprazole once monthly.
During the Screening Period, subjects can be treated with any oral antipsychotic medication
of the clinician's choice, with the exception of clozapine and olanzapine. However, oral
olanzapine is permitted during the Screening Period only for subjects who are eligible for
Phase A. Following the Screening Period, subjects who have no history of aripiprazole use
will be entered into Phase A, the Oral Tolerability Phase. Subjects from Phase A that
demonstrate tolerability to aripiprazole will then be entered into Phase B (i.e., the
Treatment Phase). Subjects who already have a history of tolerating at least three
consecutive oral doses of aripiprazole will be entered directly into Phase B. All eligible
subjects will eventually enter Phase B.
Subjects who meet the inclusion and exclusion criteria and have no history of oral
aripiprazole use will enter Phase A after the Screening Period while still hospitalized.
Subjects in Phase A will be administered oral aripiprazole, as indicated in the product
labeling, to determine tolerability. Dosage will be based on symptoms and the judgment of the
investigator. The dose of oral aripiprazole may be titrated as needed. Prior antipsychotic
medications will be tapered off and discontinued during the Screening Period and Phase A as
clinically appropriate.
During Phase A, tolerability to oral aripiprazole will be evaluated daily for a minimum of 3
days using safety and tolerability measures (i.e., AIMS, BARS, and SAS) in conjunction with
clinical judgment. If the subject shows tolerability to the oral aripiprazole, the Phase B
baseline/Day 1 should occur with the first aripiprazole once monthly injection given
immediately after the Phase B baseline/Day1 assessments. If a subject is unable to tolerate
oral aripiprazole during the tolerability assessment in Phase A, he or she will be withdrawn
from the study.
During Phase B, the subject will receive the first aripiprazole once monthly intramuscular
(IM) injection, in conjunction with the first of 14 doses of concomitant oral aripiprazole,
as indicated in the product labeling, after the baseline data are collected.
All subjects must attend scheduled visits at the Baseline Visit and Weeks 2, 4, 8, 12, 16,
20, and 24, totaling 180 days. Aripiprazole once monthly injections will occur at the
Baseline Visit and every 28 ( -2, +5) days at Weeks 4, 8, 12, 16, 20, and 24, totaling seven
injections. After the initial injection of 400 mg, the monthly dosage can be decreased to 300
mg, based on the clinical judgment of the investigator. All aripiprazole once monthly
injections will be administered based on the investigator's judgment and the prescribing
information.
For subjects who are psychiatrically stabilized and discharged prior to the completion of the
required 14-day course of oral aripiprazole, a pre-discharge assignment will be given to a
community support worker (CSW). The CSW will maintain regular contact with the subject until
the first outpatient visit in Phase B (Week 2), when oral aripiprazole will be discontinued.
Regular contact is defined as no less than weekly, but can be more frequent depending on the
clinical judgment of the CSW and outpatient treatment team. Following the Week 2 Visit,
subjects will have contact with their assigned CSW based on routine clinical care. Contact
with the CSW can be in person or by telephone, as clinically appropriate.
Note: All long-acting antipsychotics are excluded from use during the study; however,
aripiprazole once monthly is allowed
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