Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting
Overview
- Phase
- Phase 3
- Intervention
- Aripiprazole (Abilify®) IM Depot Injection
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 493
- Primary Endpoint
- Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed Description
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.
Investigators
Eligibility 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.
Arms & Interventions
OPC-14597
Aripiprazole IM depot injection 300 mg or 400 mg.
Intervention: Aripiprazole (Abilify®) IM Depot Injection
Outcomes
Primary Outcomes
Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).
Time Frame: Retrospective period Months 4-6; Prospective period Months 4-6
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).
Secondary Outcomes
- Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).(Baseline to Week 24)
- Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.(Baseline to Week 24)
- Change From Baseline in PANSS Positive Subscale Score.(Baseline to Week 24)
- Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.(Week 4, 12 and 24)
- Change From Baseline in PANSS Negative Subscale Score.(Baseline to Week 24)