Overview

Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Treatments:
Antipsychotic Agents
Aripiprazole
Criteria
Inclusion Criteria:

- Subjects who are able to provide written informed consent. If the IRB requires consent
by a legally acceptable representative in addition to the subject, all required
consents must be obtained prior to any protocol-required procedure.

- Male and female subjects 18 to 65 years of age, inclusive.

- Current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a history of
the illness for at least 1 year (12 months).

- Subjects who in the investigator's judgment would benefit from extended treatment with
a long-acting injectable formulation.

- Subjects who have at least 1 inpatient psychiatric hospitalization in the 4 years (48
months) prior to screening, but have been managed as outpatients for the 4 weeks prior
entering the study.

- Subjects must have been on oral antipsychotic treatment for the full 7 months prior to
the screening phase.

- Subjects who have shown response to previous antipsychotic treatment.

- Subjects who understand the nature of the trial and are able to follow the protocol
requirements.

Exclusion Criteria:

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or
have been incarcerated in the past 7 months for any reason must not be enrolled into
this trial.

- Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during
the trial.

- Any subject who requires or may need any other antipsychotic medications during the
course of the trial, other than allowed rescue medication.

- Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment
with aripiprazole or other quinolinones.

- Subjects with a history of hypersensitivity to antipsychotic agents.

- Subjects deemed intolerant of receiving injectable treatment.

- Subjects who have received electroconvulsive therapy within the last 7 months prior to
screening.

- Subjects with a history of neuroleptic malignant syndrome or clinically significant
tardive dyskinesia as assessed by the investigator.

- Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including
schizoaffective disorder, major depressive disorder, bipolar disorder, delirium,
dementia, amnestic or other cognitive disorders. Also, subjects with borderline,
paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.

- Subjects requiring hospitalization for any psychiatric reason during the 4 weeks prior
to signing the ICF or during the screening period.

- Subjects without at least 1 inpatient psychiatric hospitalization in the last 4 years
(48 months) prior to screening.

- Subjects who have met DSM-IV-TR criteria for any significant substance use disorder
within 3 months prior to screening.

- Subjects who are considered treatment-resistant to antipsychotic medication other than
clozapine.

- Treatment with long-acting injectable antipsychotics in which the last dose was within
7 months prior to screening.

- Subjects who have not been treated with oral antipsychotics for 7 months prior to
screening.

- Subjects who have a significant risk of committing suicide

- Subjects who have a history or evidence of a medical condition that would expose them
to an undue risk of a significant adverse event or interfere with assessments of
safety or efficacy during the course of the trial.

- Females who are pregnant or lactating, sexually active males and females who will not
commit to utilizing birth control during the trial and for up to 180 days following
the trial.

- Abnormal laboratory or physical examination results indicating a condition which may
interfere with the results of the study or pose a safety risk to the subject.

- Subjects who have previously enrolled in an aripiprazole IM depot clinical study,
except for subjects entering this trial from the Canadian 31-11-284 trial.

- Subjects who have participated in any clinical trial with an investigational agent
within the past 30 days.