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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00731549




Registration number
NCT00731549
Ethics application status
Date submitted
5/08/2008
Date registered
11/08/2008
Date last updated
26/11/2014

Titles & IDs
Public title
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Scientific title
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia
Secondary ID [1] 0 0
31-08-248
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 IM Depot

Experimental: 1 - Active Treatment of aripiprazole IM depot (300mg or 400mg)


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

Outcomes
Primary outcome [1] 0 0
Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).
Timepoint [1] 0 0
Baseline to Week 52/Last visit
Secondary outcome [1] 0 0
Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
Timepoint [1] 0 0
Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)
Secondary outcome [2] 0 0
Percentage of Participants Achieving Remission.
Timepoint [2] 0 0
Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Secondary outcome [3] 0 0
Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.
Timepoint [3] 0 0
Baseline to Week 28
Secondary outcome [4] 0 0
Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.
Timepoint [5] 0 0
Baseline, Weeks 12, 24, 52 and last visit
Secondary outcome [6] 0 0
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.
Timepoint [6] 0 0
Baseline, Weeks 12, 24, 52 and last visit
Secondary outcome [7] 0 0
Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.
Timepoint [7] 0 0
Baseline, Weeks 12, 24, 52 and last visit
Secondary outcome [8] 0 0
Mean Clinical Global Impression of Improvement (CGI-I) Score.
Timepoint [8] 0 0
Weeks 2, 4, 12, 24, 52 and last visit
Secondary outcome [9] 0 0
Percentage of Participants Who Discontinued Due to All Causes.
Timepoint [9] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
* 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.
* Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
* Subjects who complete Studies 246/247 or who withdrew from the double-blind maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or new subjects not participating in Studies 246/247.
* # Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
* Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects 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. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
* Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
* Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
* Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
* Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
* Subjects with a history of hypersensitivity to antipsychotic agents.
* Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
1081
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
- Dandenong
Recruitment hospital [2] 0 0
- Epping
Recruitment hospital [3] 0 0
- Frankston
Recruitment hospital [4] 0 0
- Fremantle
Recruitment hospital [5] 0 0
- Glenside, SA
Recruitment hospital [6] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
3175 - Dandenong
Recruitment postcode(s) [2] 0 0
3076 - Epping
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
6959 - Fremantle
Recruitment postcode(s) [5] 0 0
5063 - Glenside, SA
Recruitment postcode(s) [6] 0 0
VIC 3004 - Melbourne
Recruitment outside Australia
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United States of America
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Arizona
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Mendoza
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Pitesti
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Russian Federation
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Moscow
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Serbia
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Belgrade
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Serbia
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Taipei
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Thailand
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Chiangmai
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Thailand
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Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Covance
Address [1] 0 0
Country [1] 0 0

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00731549