Clinical trial NCT01432444: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 493
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 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.

Primary outcomes:
measure: Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).
timeFrame: Retrospective period Months 4-6; Prospective period Months 4-6
Secondary outcomes:
measure: Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.
timeFrame: Baseline to Week 24
measure: Change From Baseline in PANSS Positive Subscale Score.
timeFrame: Baseline to Week 24
measure: Change From Baseline in PANSS Negative Subscale Score.
timeFrame: Baseline to Week 24
measure: Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).
timeFrame: Baseline to Week 24
measure: Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.
timeFrame: Week 4, 12 and 24
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
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state: California
city: Anaheim
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state: California
city: Bellflower
country: United States
state: California
city: Carson
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state: California
city: Costa Mesa
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state: California
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state: California
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state: California
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state: Connecticut
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city: Norwalk
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city: Brockton
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city: Minneapolis
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city: Creve Coeur
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city: Kansas City
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city: St. Charles
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city: Lincoln
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city: North Platte
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city: Sparks
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state: Nevada
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city: Albuquerque
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state: New Mexico
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city: Brooklyn
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city: Buffalo
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city: New York
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city: New York
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city: New York
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state: New York
city: Rochester
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city: Rochester
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city: Syracuse
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city: Wards Island
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city: Charlotte
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state: North Carolina
city: Durham
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state: North Carolina
city: Canton
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state: Ohio
city: Centennial
country: United States
state: Ohio
city: Garfield Heights
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state: Ohio
city: Mason
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: McMurray
country: United States
state: Pennsylvania
city: Phoenixville
country: United States
state: Pennsylvania
city: Scranton
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state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Sioux Falls
country: United States
state: South Dakota
city: Franklin
country: United States
state: Tennessee
city: Memphis
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state: Tennessee
city: Austin
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state: Texas
city: Dallas
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state: Texas
city: Dallas
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state: Texas
city: Houston
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state: Texas
city: Houston
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state: Texas
city: San Antonio
country: United States
state: Texas
city: Wharton
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Bellevue
country: United States
state: Washington
city: Bothell
country: United States
state: Washington
city: Kirkland
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Penticton
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Brampton
country: Canada
state: Ontario
city: Chatham
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Kevin.TC-Cox@otsuka-us.com
name: Kevin Cox, MD
role: STUDY_DIRECTOR
References:
citation: Peters-Strickland T, Zhao C, Perry PP, Eramo A, Salzman PM, McQuade RD, Johnson BR, Sanchez R. Effects of aripiprazole once-monthly on symptoms of schizophrenia in patients switched from oral antipsychotics. CNS Spectr. 2016 Dec;21(6):460-465. doi: 10.1017/S1092852916000365. Epub 2016 Aug 17.
citation: Kane JM, Zhao C, Johnson BR, Baker RA, Eramo A, McQuade RD, Duca AR, Sanchez R, Peters-Strickland T. Hospitalization rates in patients switched from oral anti-psychotics to aripiprazole once-monthly: final efficacy analysis. J Med Econ. 2015 Feb;18(2):145-54. doi: 10.3111/13696998.2014.979936. Epub 2014 Nov 10.
citation: Kane JM, Sanchez R, Zhao J, Duca AR, Johnson BR, McQuade RD, Eramo A, Baker RA, Peters-Strickland T. Hospitalisation rates in patients switched from oral anti-psychotics to aripiprazole once-monthly for the management of schizophrenia. J Med Econ. 2013 Jul;16(7):917-25. doi: 10.3111/13696998.2013.804411. Epub 2013 May 28.