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

NCT ID: NCT01432444

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 493 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPC-14597

Aripiprazole IM depot injection 300 mg or 400 mg.

Group Type: EXPERIMENTAL

Aripiprazole (Abilify®) IM Depot Injection

Intervention Type: DRUG

400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.

Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013.

Interventions

Aripiprazole (Abilify®) IM Depot Injection

400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.

Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013.

Intervention Type: DRUG

Other Intervention Names

ABILIFY®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Cox, MD

Role: STUDY_DIRECTOR

Kevin.TC-Cox@otsuka-us.com

Locations

Dothan, Alabama, United States

Tucson, Arizona, United States

Fayetteville, Arkansas, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Anaheim, California, United States

Bellflower, California, United States

Carson, California, United States

Costa Mesa, California, United States

Downey, California, United States

Escondido, California, United States

Garden Grove, California, United States

Glendale, California, United States

Glendale, California, United States

Los Angeles, California, United States

National City, California, United States

Norwalk, California, United States

Oakland, California, United States

Oceanside, California, United States

Orange, California, United States

Palo Alto, California, United States

Paramount, California, United States

Pasadena, California, United States

Riverside, California, United States

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

San Francisco, California, United States

Santa Ana, California, United States

Torrance, California, United States

Middletown, Connecticut, United States

New Brittain, Connecticut, United States

Norwalk, Connecticut, United States

Boynton Beach, Florida, United States

Coral Gables, Florida, United States

Doral, Florida, United States

Hialeah, Florida, United States

Jacksonville Beach, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Oakland Park, Florida, United States

Orange City, Florida, United States

Orlando, Florida, United States

Plantation, Florida, United States

Saint Augustine, Florida, United States

South Miami, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Decatur, Georgia, United States

Marietta, Georgia, United States

Chicago, Illinois, United States

Joliet, Illinois, United States

Naperville, Illinois, United States

South Bend, Indiana, United States

Topeka, Kansas, United States

Witchita, Kansas, United States

Boston, Massachusetts, United States

Brockton, Massachusetts, United States

Newton, Massachusetts, United States

Bloomfield Hills, Michigan, United States

Grand Rapids, Michigan, United States

Paw Paw, Michigan, United States

Minneapolis, Minnesota, United States

Creve Coeur, Missouri, United States

Kansas City, Missouri, United States

Kansas City, Missouri, United States

Saint Charles, Missouri, United States

St Louis, Missouri, United States

Lincoln, Nebraska, United States

North Platte, Nebraska, United States

Sparks, Nevada, United States

Nashua, New Hampshire, United States

Albuquerque, New Mexico, United States

Amherst, New York, United States

Brooklyn, New York, United States

Brooklyn, New York, United States

Brooklyn, New York, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Rochester, New York, United States

Syracuse, New York, United States

Wards Island, New York, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Canton, Ohio, United States

Centennial, Ohio, United States

Garfield Heights, Ohio, United States

Mason, Ohio, United States

Oklahoma City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

McMurray, Pennsylvania, United States

Phoenixville, Pennsylvania, United States

Scranton, Pennsylvania, United States

Sellersville, Pennsylvania, United States

Sioux Falls, South Dakota, United States

Franklin, Tennessee, United States

Memphis, Tennessee, United States

Austin, Texas, United States

Dallas, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Wharton, Texas, United States

Salt Lake City, Utah, United States

Bellevue, Washington, United States

Bothell, Washington, United States

Kirkland, Washington, United States

Spokane, Washington, United States

Milwaukee, Wisconsin, United States

Penticton, British Columbia, Canada

Halifax, Nova Scotia, Canada

Brampton, Ontario, Canada

Chatham, Ontario, Canada

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 27531181 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25347448 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23663091 (View on PubMed)

Other Identifiers

31-11-283

Identifier Type: -

Identifier Source: org_study_id