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

Last updated: November 14, 2014
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00731549
31-08-248
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects who are able to provide written informed consent and/or consent obtained froma legally acceptable representative (as require by IRB/IEC), prior to the initiationof any protocol-required procedures.

  • Male and female subjects 18 to 65 years of age, inclusive, at time of informedconsent.

  • Subjects who complete Studies 246/247 or who withdrew from the double-blindmaintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), ornew subjects not participating in Studies 246/247.

  • Subjects who, in the investigator's judgment, require chronic treatment with anantipsychotic 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 thewritten word in order to complete patient-reported outcomes measures, and who can bereliably rated on assessment scales.

Exclusion

Exclusion Criteria:

  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, includingschizoaffective 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 antipsychotictreatment by history or response only to clozapine.

  • Subjects with a significant risk of violent behavior or a significant risk ofcommitting suicide based on history or investigator's judgment.

  • Subjects who currently meet DSM-IV-TR criteria for substance dependence; includingalcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drugscreens for cocaine.

  • Subjects who are known to be allergic, intolerant, or unresponsive to prior treatmentwith aripiprazole or other quinolinones.

  • Subjects with a history of hypersensitivity to antipsychotic agents.

  • Subjects with a history of neuroleptic malignant syndrome or clinically significanttardive dyskinesia at screening.

Study Design

Total Participants: 1081
Study Start date:
December 01, 2008
Estimated Completion Date:
November 30, 2013

Study 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 and new subjects not participating in Studies 246/247. 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.

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