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

Last updated: February 12, 2015
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Terminated

Phase

3

Condition

Mood Disorders

Psychosis

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT01509053
31-11-284
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects who are able to provide written informed consent. If the Institutional ReviewBoard (IRB) requires consent by a legally acceptable representative in addition to thesubject, all required consents must be obtained prior to any protocol-requiredprocedure.

  • Male and female subjects 18 to 65 years of age, inclusive

  • Current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual ofMental 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 witha long-acting injectable formulation

  • Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24months) prior to screening, but have been managed as outpatients for the 4 weeks priorentering the study

  • Subjects must have been on oral antipsychotic treatment for the full 7 months prior tothe screening phase Subjects who have shown response to previous antipsychotictreatment.

  • Subjects who understand the nature of the trial and are able to follow the protocolrequirements.

Exclusion

Exclusion Criteria:

  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), orhave been incarcerated in the past 7 months for any reason must not be enrolled intothis trial.

  • Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers duringthe trial.

  • Any subject who requires or may need any other antipsychotic medications during thecourse of the trial, other than allowed rescue medication.

  • Subjects who are known to be allergic, intolerant, or unresponsive to prior treatmentwith 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 toscreening.

  • Subjects with a history of neuroleptic malignant syndrome or clinically significanttardive dyskinesia as assessed by the investigator.

  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, includingschizoaffective 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 priorto 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 disorderwithin 3 months prior to screening.

  • Subjects who are considered treatment-resistant to antipsychotic medication other thanclozapine.

  • 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 toscreening.

  • Subjects who have a significant risk of committing suicide

  • Subjects who have a history or evidence of a medical condition that would expose themto an undue risk of a significant adverse event or interfere with assessments ofsafety or efficacy during the course of the trial

  • Sexually active males and females who will not commit to utilizing birth controlduring the trial and for up to 180 days following the trial.

  • Abnormal laboratory or physical examination results indicating a condition which mayinterfere 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 orwho have participated in any clinical trial with an investigational agent within thepast 30 days.

Study Design

Total Participants: 30
Study Start date:
January 01, 2012
Estimated Completion Date:
October 31, 2012

Study 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.

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  • Brugge, 8310
    Belgium

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  • Bruxelles, 1160
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  • Kortenberg, 3070
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    Liège, 4000
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  • Liège, 4000
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    Bourgas, 8000
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    Kazanlak, 6100
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  • Novi Iskar, 1282
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    Pleven, 5800
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    Plovdiv, 4000
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    Sofia, 1632
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    Tsarev brod, 9747
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  • Tzerova Koria, 5047
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    Varna, 9000
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    Calgary, Alberta T2N 2T9
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  • Penticton, British Columbia V2A 4M4
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    Vancouver, British Columbia V6A3G3
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    Victoria, British Columbia V8R 4Z3
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    Halifax, Nova Scotia B3H 2E2
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    Brampton, Ontario L6T0G1
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    Oshawa, Ontario L1G 2B9
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    Toronto, Ontario M5T 1R8
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    Montreal, Quebec H3A1A1
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    Blois cedex, Centre 41016
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    Montpellier, Herault 34295
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    La Rochelle, Poitou-Charentes 17022
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    Brumath Cedex, 67173
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    Toulon, 83000
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    Uzes, 30700
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    Siegen, NRW 57072
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    Achim, Niedersachsen 28832
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    Tuebingen, 72076
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    Cagliari, Sardinia 09127
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    Roma, 137
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    Udine, 33100
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    Voghera, 27058
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    Goyangshi, Kyeonggi-do 410-719
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    Busan, 612-862
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    Daejeon, 301-721
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    Incheon, 400-711
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    Jeonju-si, 561-712
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    Seoul, 152-703
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    Tuszyn, Lodzkie 95-080
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    Bialystok, 15-464
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    Choroszcz, 16-070
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    Piekary Slaskie, 41-940
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    Elche, 3293
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    Kaohsiung, 802
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    Keelung, 204
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    Taichung, 407
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    Tainan, 704
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    Taoyuan County, 333
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    Bury St Edmunds, Suffolk IP33 2QZ
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    Hull, Yorkshire HD6 7RX
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