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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.

Tracking Information
First Submitted Date  ICMJE May 22, 2010
First Posted Date  ICMJE May 25, 2010
Last Update Posted Date September 11, 2019
Study Start Date  ICMJE June 2010
Actual Primary Completion Date December 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01129882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2010)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia
Official Title  ICMJE An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Aripiprazole
Aripiprazole IM Depot - 300mg or 400mg
Study Arms  ICMJE Experimental: Aripiprazole IM depot
Active treatment of aripiprazole IM depot (300mg or 400mg)
Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2017)
709
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2010)
400
Actual Study Completion Date  ICMJE December 6, 2018
Actual Primary Completion Date December 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Bulgaria,   Chile,   Croatia,   Estonia,   Finland,   Hungary,   India,   Korea, Republic of,   Malaysia,   Mexico,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01129882
Other Study ID Numbers  ICMJE 31-10-270
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP