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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01129882




Registration number
NCT01129882
Ethics application status
Date submitted
22/05/2010
Date registered
25/05/2010

Titles & IDs
Public title
An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia
Scientific title
An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia
Secondary ID [1] 0 0
31-10-270
Universal Trial Number (UTN)
Trial acronym
ASPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aripiprazole

Experimental: Aripiprazole IM depot - Active treatment of monthly doses of aripiprazole IM depot (300 mg or 400 mg)


Treatment: Drugs: Aripiprazole
Aripiprazole IM depot - 300 mg or 400 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE)
Timepoint [1] 0 0
Baseline to Month 97 (+/- 3 days)
Secondary outcome [1] 0 0
Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit
Timepoint [1] 0 0
Baseline, Month 91

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/12/2018
Sample size
Target
Accrual to date
Final
709
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
- Epping
Recruitment hospital [2] 0 0
- Frankston
Recruitment hospital [3] 0 0
- Fremantle
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
6959 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Connecticut
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District of Columbia
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Florida
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Illinois
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Mississippi
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Missouri
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Nebraska
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New York
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North Carolina
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Oklahoma
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Bulgaria
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Bourgas
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Lovech
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Pazardzhik
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Pleven
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Plovdiv
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Radnevo
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Rousse
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Sofia
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Tserova Koria
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Varna
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Temuco
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Chile
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Croatia
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Zagreb
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Tallinn
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Tartu
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Finland
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Gyõr
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India
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Moscow
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Nizhny Novgorod
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Smolensk
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Russian Federation
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St. Petersburg
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Slovakia
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Bardejov
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Kosice
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Liptovsky Mikulas
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Prešov
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Slovakia
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Rimavská Sobota
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South Africa
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Western Province
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South Africa
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Bellville
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South Africa
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Pretoria West
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Spain
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Barcelona
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Spain
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Hospitalet de Llobregat
Country [100] 0 0
Taiwan
State/province [100] 0 0
Tainan
Country [101] 0 0
Taiwan
State/province [101] 0 0
Taipei City
Country [102] 0 0
Thailand
State/province [102] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01129882