NCT01646827

An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia

An Open-label, Randomized, Parallel Arm, Bioavailability Trial of Aripiprazole IM Depot Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body

Detailed description

Extended-release gluteal intramuscular (IM) injection of aripiprazole has been tested in subjects with schizophrenia for safety and tolerability. This study will compare the gluteal IM aripiprazole injection with deltoid IM aripiprazole injection for safety and tolerability.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole IM Depot	One injection of 400 mg aripiprazole IM depot

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-07-20
• Last updated: 2014-07-31
• Results posted: 2014-07-31

Locations

6 sites across 1 country: United States