Tracking Information
Start Date ICMJE | December 2008 |
---|---|
Estimated Primary Completion Date | July 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 ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00731549 on ClinicalTrials.gov 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 ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia |
---|---|
Official Title ICMJE | A 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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Schizophrenia |
Intervention ICMJE | Drug: Aripiprazole IM Depot 300mg or 400mg Other Name: Oral Aripiprazole |
Study Arms / Comparison Groups | 1: Experimental Active Treatment of aripiprazole IM depot (300mg or 400mg) Intervention: Drug: Aripiprazole IM Depot |
Recruitment Information
Recruitment Status ICMJE | Recruiting | ||||
---|---|---|---|---|---|
Estimated Enrollment ICMJE | 500 | ||||
Completion Date | |||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | United 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
NCT ID ICMJE | NCT00731549 |
---|---|
Responsible Party | Juan Torres Project Director, Covance, Inc. |
Study ID Numbers ICMJE | 31-08-248 |
Study Sponsor ICMJE | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Collaborators ICMJE | Covance |
Investigators ICMJE | |
Information Provided By | Otsuka Pharmaceutical Development & Commercialization, Inc. |