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

December 17, 2019 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This was an open-label study that enrolled participants with schizophrenia who had completed the 52-week, open-label safety and tolerability Study 31-08-248 and continued to provide aripiprazole IM depot treatment.

Participants received this treatment until aripiprazole IM Depot was commercially available in any dosage (including generic formulations) in the country where the study was being conducted or the commercial availability of aripiprazole IM Depot was terminated by the sponsor, or until the study completion date of 06 Dec 2018 was reached.

Eligible participants entered this study at the end of treatment visit (Week 52) of Study 31-08-248. Participants continued to receive aripiprazole IM depot every month (study months were every 4 weeks, which were defined as 28 [-2/+10] days) as a continuation of their previous monthly dose in Study 31-08-248.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
709

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405BOA
      • Buenos Aires, Argentina, C1425AHQ
      • Buenos Aires, Argentina, 1900
      • Buenos Aires, Argentina, C1058AAH
      • Mendoza, Argentina, M5500HYF
  • Australia
    • Victoria
      • Epping, Victoria, Australia, 3076
      • Frankston, Victoria, Australia, 3199
    • Western Australia
      • Fremantle, Western Australia, Australia, 6959
  • Bulgaria
      • Bourgas, Bulgaria, 8000
      • Lovech, Bulgaria, 5500
      • Pazardzhik, Bulgaria, 4400
      • Pleven, Bulgaria, 5800
      • Plovdiv, Bulgaria
      • Plovdiv, Bulgaria, 4002
      • Radnevo, Bulgaria, 6260
      • Rousse, Bulgaria, 7003
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1113
      • Sofia, Bulgaria, 1632
      • Tserova Koria, Bulgaria
      • Varna, Bulgaria
      • Varna, Bulgaria, 9001
  • Chile
      • Santiago, Chile, 7500710
      • Santiago, Chile, 7510186
      • Santiago, Chile, 7580307
      • Santiago, Chile, 8330838
      • Santiago, Chile, 8900085
      • Santiago, Chile, 8780000
      • Temuco, Chile, 4781151
      • Valdivia, Chile, 5090145
  • Croatia
      • Zagreb, Croatia, 10000
      • Zagreb, Croatia, 10090
      • Zagreb, Croatia
  • Estonia
      • Tallinn, Estonia, 10617
      • Tallinn, Estonia, 10614
      • Tartu, Estonia
      • Tartu, Estonia, 50417
      • Viljandi, Estonia, 71024
  • Finland
      • Helsinki, Finland, 250
  • Hungary
      • Baja, Hungary, 6500
      • Balassagyarmat, Hungary, 2660
      • Gyõr, Hungary, 9023
  • India
      • Bangalore, India
      • Chennai, India
      • Kanpur, India, 208005
      • Pune, India, 411004
      • Tirupati, India, 517507
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
    • Karnataka
      • Mangalore, Karnataka, India, 575018
  • 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
      • Ipoh, Malaysia
      • Kajang, Malaysia
      • Kuala Lumpur, Malaysia, 59100
      • Kuala Lumpur, Malaysia, 56000
  • Mexico
      • Mexico, Mexico, 7760
      • San Luis Potosí, Mexico, 78218
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64040
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80020
  • Philippines
      • Mariveles, Philippines
    • NCR
      • Mandaluyong City, NCR, Philippines, 1553
    • Western Visayas
      • Iloilo City, 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
      • Leningrad, Russian Federation
      • Lipetsk, Russian Federation, 398007
      • Moscow, Russian Federation, 115522
      • Moscow, Russian Federation, 127083
      • Nizhny Novgorod, Russian Federation, 603152
      • Nizhny Novgorod, Russian Federation, 603155
      • Smolensk, Russian Federation
      • St. Petersburg, Russian Federation, 190121
      • St. Petersburg, Russian Federation, 192019
  • Serbia
      • Belgrade, Serbia, 11000
      • Kragujevac, Serbia, 34000
  • Slovakia
      • Bardejov, Slovakia
      • Kosice, Slovakia, 041 90
      • Liptovsky Mikulas, Slovakia, 3101
      • Prešov, Slovakia
      • Rimavská Sobota, Slovakia
  • South Africa
      • Bellville, South Africa, 7530
      • Pretoria West, South Africa, 1
    • Western Province
      • Cape Town, Western Province, South Africa, 7530
  • Spain
      • Barcelona, Spain, 8036
      • Barcelona, Spain, 08006
      • Hospitalet de Llobregat, Spain
  • Taiwan
      • Tainan, Taiwan, 704
      • Taipei City, Taiwan, 110
  • Thailand
      • Chiang Mai, Thailand
  • United States
    • California
      • Bellevue, California, United States, 98007
      • Garden Grove, California, United States, 92845
      • Glendale, California, United States, 91206
      • Glendale, California, United States, 91204
      • Imperial, California, United States, 92251
      • Los Angeles, California, United States, 90024
      • National City, California, United States
      • National City, California, United States, 91950
      • Orange, California, United States, 92868
      • Pasadena, California, United States, 91107
      • Pico Rivera, California, United States, 90660
      • Pico Rivera, California, United States
      • San Bernardino, California, United States, 92408-3304
      • San Diego, California, United States
      • Sherman Oaks, California, United States, 91403
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
    • District of Columbia
      • Washington, District of Columbia, United States
      • Washington, District of Columbia, United States, 20016
    • Florida
      • Bradenton, Florida, United States
      • Doral, Florida, United States
      • Hialeah, Florida, United States, 33016
      • Homestead, Florida, United States, 33030
      • Orange City, Florida, United States, 32763
      • Tampa, Florida, United States, 33613
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Chicago, Illinois, United States, 60640
      • Oak Brook, Illinois, United States, 60523
    • Indiana
      • Indianapolis, Indiana, United States, 46222
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Missouri
      • Saint Louis, Missouri, United States, 63109
    • Nebraska
      • North Platte, Nebraska, United States, 69101
    • New York
      • Buffalo, New York, United States, 14215
      • New York, New York, United States, 10035
      • Queens, New York, United States
      • Rochester, New York, United States, 14615
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
    • Ohio
      • Akron, Ohio, United States
      • Canton, Ohio, United States, 44718
      • Toledo, Ohio, United States, 43609
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
      • Jenkintown, Pennsylvania, United States, 19046
      • Sellersville, Pennsylvania, United States, 18960
    • South Carolina
      • Charleston, South Carolina, United States, 29401
    • Tennessee
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Austin, Texas, United States, 78731
      • Austin, Texas, United States, 78754
      • DeSoto, Texas, United States, 75115
    • Virginia
      • Richmond, Virginia, United States, 23230
    • Washington
      • Bothell, Washington, United States, 98011
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, who completed the open-label extension Study 248 (completed Study 248 study completion visit, Week 52).
  • Participants 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 was defined as 28 [-2/+10] days) of the last injection in Study 248.
  • Participants who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by an Independent Review Board/Independent Ethics Committee (IRB/IEC), prior to the initiation of any protocol-required procedures.
  • Participants 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:

  • Participants 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.
  • Participants with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
  • Participants who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine.
  • Participants with a significant risk of violent behavior or a significant risk of committing suicide based on the investigator's judgment.
  • Participants who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
  • Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
  • Electroconvulsive therapy within 180 days prior to entry.
  • Any participant 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 participant's country.
  • Other protocol specific inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aripiprazole IM depot
Active treatment of monthly doses of aripiprazole IM depot (300 mg or 400 mg)
Drug: Aripiprazole
Aripiprazole IM depot - 300 mg or 400 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE)
Time Frame: Baseline to Month 97 (+/- 3 days)

A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity.

A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Baseline to Month 97 (+/- 3 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit
Time Frame: Baseline, Month 91
The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The Last Visit was defined as the last available post-baseline evaluation. A decrease in the CGI-S score indicated disease stability or improvement.
Baseline, Month 91

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 31-10-270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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