Clinical trial NCT01509053: Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
Official title: 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, Europe, Canada and Asia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Subjects who are able to provide written informed consent. If the Institutional Review Board (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 Diagnostic and Statistical Manual of Mental Disorders (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 2 years (24 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 Informed Consent Form (ICF) or during the screening period.
* Subjects without at least 1 inpatient psychiatric hospitalization in the last 2 years (24 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
* 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 or who have participated in any clinical trial with an investigational agent within the past 30 days.

Primary outcomes:
measure: Comparison of Inpatient Psychiatric Hospitalization Rates
timeFrame: Retrospective period Months 4-6; Prospective period Months 4-6
Secondary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline, Week 24
measure: Change From Baseline in PANSS Positive and Negative Subscale Scores
timeFrame: Baseline, Week 24
measure: Clinical Global Impression of Severity (CGI-S) Score
timeFrame: Baseline, Week 24
measure: Clinical Global Impression of Improvement (CGI-I) Score
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Kortenberg
country: Belgium
city: Liège
country: Belgium
city: Lovech
country: Bulgaria
city: Novi Iskar
country: Bulgaria
city: Pazardjik
country: Bulgaria
city: Tzerova Koria
country: Bulgaria
city: Penticton
country: Canada
state: British Columbia
city: Chatham
country: Canada
state: Ontario
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Tim Peters-Strickland
role: STUDY_DIRECTOR
References: