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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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). - "Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score = 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of = 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) = 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) = 2 (mildly suicidal) on Part 1 and = 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here.
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. - "Impending relapse criteria" was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) = 5 (minimally worse), AND an increase to score of >4 and absolute increase of = 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of = 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage.
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. - Remission is defined as a score of = 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.
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. - "Stable" was defined as meeting all of the following criteria: Outpatient status; PANSS total score = 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of = 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) = 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) = 2 (mildly suicidal) on Part 1 and = 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here.
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. - Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.
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. - PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
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. - To assess CGI-S, the rater or physician will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 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 participants.
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. - PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
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. - To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
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. - Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.
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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
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- Dandenong
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- Epping
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- Frankston
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- Fremantle
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- Glenside, SA
Recruitment hospital [6] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
3175 - Dandenong
Recruitment postcode(s) [2] 0 0
3076 - Epping
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3199 - Frankston
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6959 - Fremantle
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5063 - Glenside, SA
Recruitment postcode(s) [6] 0 0
VIC 3004 - Melbourne
Recruitment outside Australia
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Serbia
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Serbia
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Kragujevac
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Chiangmai
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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
To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance
treatment in patients with schizophrenia.
Trial website
https://clinicaltrials.gov/show/NCT00731549
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
Other publications