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An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia (ASPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01129882
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
Purpose: To continue to provide aripiprazole intramuscular (IM) Depot treatment (400 mg or 300 mg) to subjects with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Phase 3

Detailed Description:

This is an open-label study which will enroll subjects with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248 and will continue to provide aripiprazole intramuscular (IM) Depot treatment.

Subjects can receive this treatment until aripiprazole IM Depot is commercially available in any dosage (including generic formulations) in the country that the study is being conducted or the commercial availability of aripiprazole IM Depot is terminated by the sponsor, or until the study end date of 31 Dec 2018 is reached.

Eligible subjects will enter this study at the End of Treatment visit (Week 52) of Study 248. Subjects will continue to receive aripiprazole IM Depot every month (study months are every 4 weeks which is defined as 28 [-2/+10] days) as a continuation of their previous monthly dose in Study 248.

Recruitment is closed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 709 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia
Study Start Date : June 2010
Actual Primary Completion Date : December 6, 2018
Actual Study Completion Date : December 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Aripiprazole IM depot
Active treatment of aripiprazole IM depot (300mg or 400mg)
Drug: Aripiprazole
Aripiprazole IM Depot - 300mg or 400mg




Primary Outcome Measures :
  1. Frequency and severity of adverse effects and serious adverse effects [ Time Frame: 4 weeks ]

    The primary measures are (1) frequency and severity of adverse events, (2) frequency and severity of serious adverse events (including adverse events related to laboratory abnormalities), and (3) rates of discontinuation from study due to adverse events.

    Safety and tolerability data will be summarized as follows: incidence of adverse events and serious adverse events (with severity grades) will be tabulated by MedDRA terms; incidence of discontinuations due to AE will be tabulated by MedDRA terms.



Secondary Outcome Measures :
  1. Mean change from baselines [ Time Frame: 4 weeks ]

    Mean change from baseline of vital signs parameters, laboratory tests, and ECG parameters will be provided by visit. Incidence of clinically significant abnormalities in vital signs parameters, laboratory tests, and ECG parameters will be tabulated. Weight gain or loss and injection site reactions will be summarized.

    Mean and mean change from baseline in the efficacy endpoint CGI-S score will be summarized.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria, who completed the open-label extension Study 248 (completed Study 248 study completion visit, Week 52).
  • Subjects who, in the investigator's judgment, may benefit from continued participation in an aripiprazole IM Depot study.
  • The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the first injection for Study 270 must occur within 4 weeks (which is defined as 28 [-2/+10] days) of the last injection in Study 248.
  • Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures.
  • Subjects able to understand the nature of the study and follow protocol requirements and who can read and understand the written word in order to complete patient-reported outcomes measures.
  • Outpatient status.

Exclusion Criteria:

  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, MDD, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
  • Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
  • Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on the investigator's judgment.
  • Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
  • Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
  • Electroconvulsive therapy within 180 days prior to entry.
  • Any subject who requires or may need any other antipsychotic medications during the course of the study.
  • Aripiprazole IM Depot (including generic formulation) is commercially available in the subject's country.
  • Other protocol specific inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129882


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Locations
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United States, California
Anaheim, California, United States, 92804
Bellevue, California, United States, 98007
Escondido, California, United States, 92025
Garden Grove, California, United States, 92845
Glendale, California, United States, 91204
Glendale, California, United States, 91206
Imperial, California, United States, 92251
Los Angeles, California, United States, 90024
National City, California, United States, 91950
Oceanside, California, United States, 92056
Orange, California, United States, 92868
Pasadena, California, United States, 91107
Pico Rivera, California, United States, 90660
San Bernardino, California, United States, 92408-3304
San Diego, California, United States, 92102
San Diego, California, United States, 92123
Sherman Oaks, California, United States, 91403
Torrance, California, United States, 90502
United States, Connecticut
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Washington, District of Columbia, United States, 20016
United States, Florida
Hialeah, Florida, United States, 33016
Homestead, Florida, United States, 33030
Maitland, Florida, United States, 32751
Miami Springs, Florida, United States, 33166
Orange City, Florida, United States, 32763
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta, Georgia, United States, 30328
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60640
Oakbrook Terrace, Illinois, United States, 60523
United States, Indiana
Indianapolis, Indiana, United States, 46222
United States, Louisiana
Shreveport, Louisiana, United States, 71101
United States, Mississippi
Flowood, Mississippi, United States, 39232
United States, Missouri
Saint Louis, Missouri, United States, 63109
United States, Nebraska
North Platte, Nebraska, United States, 69101
United States, New York
Buffalo, New York, United States, 14215
Jamaica, New York, United States, 11418
New York, New York, United States, 10035
Rochester, New York, United States, 14615
United States, North Carolina
Charlotte, North Carolina, United States, 28204
United States, Ohio
Canton, Ohio, United States, 44718
Garfield Heights, Ohio, United States, 44125
Toledo, Ohio, United States, 43609
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18104
Jenkintown, Pennsylvania, United States, 19046
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Charleston, South Carolina, United States, 29401
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Austin, Texas, United States, 78731
Austin, Texas, United States, 78754
DeSoto, Texas, United States, 75115
United States, Virginia
Richmond, Virginia, United States, 23230
United States, Washington
Bothell, Washington, United States, 98011
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Argentina
La Plata, Buenos Aires, Argentina, 1900
Buenos Aires, Argentina, C1058AAH
Buenos Aires, Argentina, C1405BOA
Mendoza, Argentina, M5500HYF
Palermo, Buenos Aires, Argentina, C1425AHQ
Australia, Victoria
Epping, Victoria, Australia, 3076
Frankston, Victoria, Australia, 3199
Australia, Western Australia
Fremantle, Western Australia, Australia, 6959
Bulgaria
Bourgas, Bulgaria, 8000
Lovech, Bulgaria, 5500
Pazardjik, Bulgaria, 4400
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Radnevo, Bulgaria, 6260
Rousse, Bulgaria, 7003
Sofia, Bulgaria, 1113
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1632
Varna, Bulgaria, 9001
Veliko Tarnovo, Bulgaria, 5007
Chile
Muang, Chiangmai, Chile, 50200
San Bernardo, Santiago, Chile, 8780000
Santiago, Chile, 7500710
Santiago, Chile, 7510186
Santiago, Chile, 7580307
Santiago, Chile, 8330838
Santiago, Chile, 8900085
Temuco, Chile, 4781151
Valdivia, Chile, 5090145
Croatia
Zagreb, Croatia, 10000
Zagreb, Croatia, 10090
Estonia
Tallinn, Estonia, 10614
Tallinn, Estonia, 10617
Tartu, Estonia, 50417
Viljandi, Estonia, 71024
Finland
Helsinki, Finland, 250
Hungary
Baja, Hungary, 6500
Balassagyarmat, Hungary, 2660
Gyor, Hungary, 9023
India
Ahmedabad, Gujarat, India, 380006
Mangalore, Karnataka, India, 575018
Kanpur, India, 208005
Pune, India, 411004
Tirupati, India, 517507
Korea, Republic of
Daejeon, Korea, Republic of, 301-721
Gwangju, Korea, Republic of, 501-757
Incheon, Korea, Republic of, 400-711
Seoul, Korea, Republic of, 110-744
Malaysia
Kajang Selangor, Malaysia, 43000
Kuala Lumpur, Malaysia, 56000
Kuala Lumpur, Malaysia, 59100
Perak, Malaysia, 31250
Mexico
Guadalajara, Jalisco, Mexico, 44280
Monterrey, Nuevo León, Mexico, 64040
Culiacan, Sinaloa, Mexico, 80020
Mexico, D.F., Mexico, 7760
San Luis Potosí, Mexico, 78218
Philippines
Bataan, Central Luzon, Philippines, 2105
Mandaluyong, NCR, Philippines, 1553
Iloilo, Western Visayas, Philippines, 5000
Poland
Belchatow, Poland, 97-400
Bialystok, Poland, 15-879
Bydgoszcz, Poland, 85096
Choroszcz, Poland, 16-070
Krakow, Poland, 31-501
Leszno, Poland, 64-100
Sosnowiec, Poland, 41-200
Wroclaw, Poland, 50-227
Puerto Rico
San Juan, Puerto Rico, 00918
Romania
Arad, Romania, 310022
Bucharest, Romania, 41914
Cluj-napoca, Romania, 400012
Craiova, Romania, 200620
Oradea, Romania, 410163
Pitesti, Romania, 110069
Russian Federation
Lipetsk, Russian Federation, 398007
Moscow, Russian Federation, 115522
Moscow, Russian Federation, 127083
Nizhny Novgorod, Russian Federation, 603152
Nizhny Novgorod, Russian Federation, 603155
St. Petersburg, Russian Federation, 190121
St. Petersburg, Russian Federation, 192019
Serbia
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
Slovakia
Kosice, Slovakia, 041 90
Liptovsky Mikulas, Slovakia, 3101
Svidnik, Slovakia, 089 01
South Africa
Cape Town, Western Province, South Africa, 7530
Bellville, South Africa, 7530
Pretoria West, South Africa, 1
Spain
Barcelona, Spain, 08006
Barcelona, Spain, 8036
Catalonia, Spain, 08907
Taiwan
Tainan, Taiwan, 704
Taipei, Taiwan, 110
Thailand
Muang, Thailand, 50200
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01129882     History of Changes
Other Study ID Numbers: 31-10-270
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Schizophrenia
Additional relevant MeSH terms:
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Aripiprazole
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists