Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
6/01/2020

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
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Mendoza
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Bourgas
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Lovech
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Pazardzhik
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Pleven
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Plovdiv
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Radnevo
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Rousse
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Sofia
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Tserova Koria
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Varna
Country [34] 0 0
Chile
State/province [34] 0 0
Santiago
Country [35] 0 0
Chile
State/province [35] 0 0
Temuco
Country [36] 0 0
Chile
State/province [36] 0 0
Valdivia
Country [37] 0 0
Croatia
State/province [37] 0 0
Zagreb
Country [38] 0 0
Estonia
State/province [38] 0 0
Tallinn
Country [39] 0 0
Estonia
State/province [39] 0 0
Tartu
Country [40] 0 0
Estonia
State/province [40] 0 0
Viljandi
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
Country [42] 0 0
Hungary
State/province [42] 0 0
Baja
Country [43] 0 0
Hungary
State/province [43] 0 0
Balassagyarmat
Country [44] 0 0
Hungary
State/province [44] 0 0
Gyõr
Country [45] 0 0
India
State/province [45] 0 0
Gujarat
Country [46] 0 0
India
State/province [46] 0 0
Karnataka
Country [47] 0 0
India
State/province [47] 0 0
Bangalore
Country [48] 0 0
India
State/province [48] 0 0
Chennai
Country [49] 0 0
India
State/province [49] 0 0
Kanpur
Country [50] 0 0
India
State/province [50] 0 0
Pune
Country [51] 0 0
India
State/province [51] 0 0
Tirupati
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Daejeon
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Gwangju
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Incheon
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seoul
Country [56] 0 0
Malaysia
State/province [56] 0 0
Ipoh
Country [57] 0 0
Malaysia
State/province [57] 0 0
Kajang
Country [58] 0 0
Malaysia
State/province [58] 0 0
Kuala Lumpur
Country [59] 0 0
Mexico
State/province [59] 0 0
Jalisco
Country [60] 0 0
Mexico
State/province [60] 0 0
Nuevo León
Country [61] 0 0
Mexico
State/province [61] 0 0
Sinaloa
Country [62] 0 0
Mexico
State/province [62] 0 0
Mexico
Country [63] 0 0
Mexico
State/province [63] 0 0
San Luis Potosí
Country [64] 0 0
Philippines
State/province [64] 0 0
NCR
Country [65] 0 0
Philippines
State/province [65] 0 0
Western Visayas
Country [66] 0 0
Philippines
State/province [66] 0 0
Mariveles
Country [67] 0 0
Poland
State/province [67] 0 0
Belchatow
Country [68] 0 0
Poland
State/province [68] 0 0
Bialystok
Country [69] 0 0
Poland
State/province [69] 0 0
Bydgoszcz
Country [70] 0 0
Poland
State/province [70] 0 0
Choroszcz
Country [71] 0 0
Poland
State/province [71] 0 0
Krakow
Country [72] 0 0
Poland
State/province [72] 0 0
Leszno
Country [73] 0 0
Poland
State/province [73] 0 0
Sosnowiec
Country [74] 0 0
Poland
State/province [74] 0 0
Wroclaw
Country [75] 0 0
Puerto Rico
State/province [75] 0 0
San Juan
Country [76] 0 0
Romania
State/province [76] 0 0
Arad
Country [77] 0 0
Romania
State/province [77] 0 0
Bucharest
Country [78] 0 0
Romania
State/province [78] 0 0
Cluj-Napoca
Country [79] 0 0
Romania
State/province [79] 0 0
Craiova
Country [80] 0 0
Romania
State/province [80] 0 0
Oradea
Country [81] 0 0
Romania
State/province [81] 0 0
Pitesti
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Leningrad
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Lipetsk
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Moscow
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Nizhny Novgorod
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Smolensk
Country [87] 0 0
Russian Federation
State/province [87] 0 0
St. Petersburg
Country [88] 0 0
Serbia
State/province [88] 0 0
Belgrade
Country [89] 0 0
Serbia
State/province [89] 0 0
Kragujevac
Country [90] 0 0
Slovakia
State/province [90] 0 0
Bardejov
Country [91] 0 0
Slovakia
State/province [91] 0 0
Kosice
Country [92] 0 0
Slovakia
State/province [92] 0 0
Liptovsky Mikulas
Country [93] 0 0
Slovakia
State/province [93] 0 0
Prešov
Country [94] 0 0
Slovakia
State/province [94] 0 0
Rimavská Sobota
Country [95] 0 0
South Africa
State/province [95] 0 0
Western Province
Country [96] 0 0
South Africa
State/province [96] 0 0
Bellville
Country [97] 0 0
South Africa
State/province [97] 0 0
Pretoria West
Country [98] 0 0
Spain
State/province [98] 0 0
Barcelona
Country [99] 0 0
Spain
State/province [99] 0 0
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
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.
Trial website
https://clinicaltrials.gov/study/NCT01129882
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01129882