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

NCT01432444 | Completed Phase 3 Results

• 1 other identifier: 31-11-283
• Study Type: interventional
• Target: 493
• Locations: 2 countries
• Sites: 124

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.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and 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).

  Retrospective period Months 4-6; Prospective period Months 4-6

Secondary Outcomes (5)

• 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

• Change From Baseline in PANSS Negative Subscale Score.

  Baseline to Week 24

• Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).

  Baseline to Week 24

• Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.

  Week 4, 12 and 24

Study Arms (1)

OPC-14597

EXPERIMENTAL

Aripiprazole IM depot injection 300 mg or 400 mg.

Drug: Aripiprazole (Abilify®) IM Depot Injection

Interventions

Aripiprazole (Abilify®) IM Depot Injection 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.

Also known as: ABILIFY®

OPC-14597

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (124)

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Dothan, Alabama, 36305, United States

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Tucson, Arizona, 85719, United States

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Fayetteville, Arkansas, 72703, United States

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Little Rock, Arkansas, 72201, United States

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Anaheim, California, 92801, United States

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Anaheim, California, 92804, United States

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Bellflower, California, 90706, United States

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Carson, California, 90746, United States

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Costa Mesa, California, 92626, United States

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Downey, California, 90241, United States

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Escondido, California, 92025, United States

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Garden Grove, California, 92845, United States

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Glendale, California, 91204, United States

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Glendale, California, 91206, United States

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Los Angeles, California, United States

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National City, California, 91950, United States

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Norwalk, California, 60950, United States

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Oakland, California, 94612, United States

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Oceanside, California, 92056, United States

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Orange, California, United States

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Palo Alto, California, 94304, United States

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Paramount, California, 92626, United States

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Pasadena, California, 91106-2500, United States

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Riverside, California, 92506, United States

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San Diego, California, 92108, United States

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San Diego, California, 92117, United States

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San Diego, California, 92121, United States

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San Francisco, California, 94104, United States

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Santa Ana, California, 92705, United States

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Torrance, California, 90502, United States

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Middletown, Connecticut, 06457, United States

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New Brittain, Connecticut, 06050, United States

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Norwalk, Connecticut, 06851, United States

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Boynton Beach, Florida, 33435, United States

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Coral Gables, Florida, 33134, United States

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Doral, Florida, 33172, United States

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Hialeah, Florida, 33014, United States

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Jacksonville Beach, Florida, 32250, United States

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Miami, Florida, 33122, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33155, United States

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Oakland Park, Florida, 33334, United States

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Orange City, Florida, 32763, United States

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Orlando, Florida, 32803, United States

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Plantation, Florida, 33317, United States

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Saint Augustine, Florida, 32086, United States

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South Miami, Florida, 33143, United States

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St. Petersburg, Florida, 33716, United States

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Tampa, Florida, 33559, United States

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Tampa, Florida, 33613, United States

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Atlanta, Georgia, 30301, United States

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Decatur, Georgia, 30030, United States

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Marietta, Georgia, 30062, United States

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Chicago, Illinois, 60611-4296, United States

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Joliet, Illinois, 60435, United States

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Naperville, Illinois, 60563, United States

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South Bend, Indiana, 46617, United States

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Topeka, Kansas, 66606, United States

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Witchita, Kansas, 67207, United States

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Boston, Massachusetts, 02114, United States

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Brockton, Massachusetts, 02301, United States

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Newton, Massachusetts, 02458, United States

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Bloomfield Hills, Michigan, 48302, United States

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Grand Rapids, Michigan, 49503, United States

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Paw Paw, Michigan, 49079, United States

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Minneapolis, Minnesota, 55454, United States

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Creve Coeur, Missouri, 63141, United States

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Kansas City, Missouri, 64108, United States

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Kansas City, Missouri, 64114, United States

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Saint Charles, Missouri, 63301, United States

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St Louis, Missouri, 63128, United States

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Lincoln, Nebraska, 68526, United States

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North Platte, Nebraska, 69101, United States

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Sparks, Nevada, 89434, United States

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Nashua, New Hampshire, 03060, United States

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Albuquerque, New Mexico, 87106, United States

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Amherst, New York, 14226, United States

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Brooklyn, New York, 11203, United States

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Brooklyn, New York, 11206, United States

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Brooklyn, New York, 11241, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10027, United States

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New York, New York, 10065, United States

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New York, New York, 10128, United States

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Rochester, New York, 14615, United States

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Rochester, New York, 14618, United States

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Syracuse, New York, 13202, United States

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Wards Island, New York, 10035, United States

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Charlotte, North Carolina, 28204, United States

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Durham, North Carolina, 27704, United States

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Canton, Ohio, 44718, United States

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Centennial, Ohio, 80112, United States

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Garfield Heights, Ohio, 44125, United States

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Mason, Ohio, 45040, United States

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Oklahoma City, Oklahoma, 73112, United States

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Oklahoma City, Oklahoma, United States

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McMurray, Pennsylvania, 15317, United States

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Phoenixville, Pennsylvania, 19460, United States

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Scranton, Pennsylvania, 18503, United States

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Sellersville, Pennsylvania, 18960, United States

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Sioux Falls, South Dakota, 57105, United States

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Franklin, Tennessee, 37067, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75390-8828, United States

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Houston, Texas, 77054, United States

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Houston, Texas, 77081, United States

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San Antonio, Texas, 78229, United States

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Wharton, Texas, 77488, United States

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Salt Lake City, Utah, 84105, United States

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Bellevue, Washington, 98007, United States

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Bothell, Washington, 98011, United States

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Kirkland, Washington, 98033, United States

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Spokane, Washington, 99204, United States

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Milwaukee, Wisconsin, 53226, United States

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Penticton, British Columbia, V2A 4M4, Canada

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Halifax, Nova Scotia, B3H 2E2, Canada

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Brampton, Ontario, L6T 0G1, Canada

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Chatham, Ontario, N7M 5L9, Canada

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Montreal, Quebec, H3A1A1, Canada

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Related Publications (3)

• 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.

  PMID: 27531181 DERIVED

• 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.

  PMID: 25347448 DERIVED

• 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.

  PMID: 23663091 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Kevin Cox, MD

  Kevin.TC-Cox@otsuka-us.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 13, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 7, 2015
• Results First Posted: March 27, 2015

Record last verified: 2015-04

Locations

CA (5); US (119)