Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (ASPIRE)

Tracking Information

Start Date  ICMJEDecember 2008
Estimated Primary Completion DateJuly 2013   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 7, 2008)
The proportion of subjects who are stable at baseline of Phase 3 and maintain stability at endpoint [ Time Frame: Bi-weekly for 12 weeks and every 4 weeks for 40 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00731549 on Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 7, 2008)
Percentage of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria [ Time Frame: Bi-weekly for 12 weeks and every 4 weeks for 40 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEIntramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Official Title  ICMJEA 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia
Brief Summary

To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

Detailed Description

This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of Study 31-07-246 and Phase 3 of Study 31- 07-247. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e., 31-07-246 or 31-07-247).

This open-label study will be comprised of phases similar to the pivotal double-blind studies (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase (Phase 1, if applicable), an oral stabilization phase (Phase 2), and an IM depot open-label maintenance phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week follow-up period.

During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will be allowed for subjects who do not meet stability criteria or meet the criteria for impending relapse/exacerbation of psychotic symptoms.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJESchizophrenia
Intervention  ICMJEDrug: Aripiprazole IM Depot
300mg or 400mg
Other Name: Oral Aripiprazole
Study Arms / Comparison Groups1: Experimental
Active Treatment of aripiprazole IM depot (300mg or 400mg)
Intervention: Drug: Aripiprazole IM Depot

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE500
Completion Date 
Estimated Primary Completion DateJuly 2013   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and subjects withdrawn from Studies 246 (Phase 4) /247 (Phase 3) for a reason other than exacerbation of psychotic symptoms/impending relapse are eligible for enrollment
  • 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.

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.
  • 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.
  • 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.
Ages18 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Clinical Contact Line1-866-670-3668
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Chile,   China,   Croatia,   Denmark,   Estonia,   Finland,   France,   Greece,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Norway,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Sweden,   Taiwan,   Thailand,   United Kingdom

Administrative Information

Responsible PartyJuan Torres Project Director, Covance, Inc.
Study ID Numbers  ICMJE31-08-248
Study Sponsor  ICMJEOtsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJECovance
Investigators  ICMJE 
Information Provided ByOtsuka Pharmaceutical Development & Commercialization, Inc.