NCT01870999

A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot

An Open-label Parallel Arm Multiple Dose Tolerability, Pharmacokinetics and Safety Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot Formulation Once Every Four Weeks

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	aripiprazole IM depot	Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.
DRUG	aripiprazole tablets	Aripiprazole tablets 10 mg once daily in the morning for 14 days.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2013-06-06
• Last updated: 2014-01-22
• Results posted: 2014-01-22

Locations

7 sites across 1 country: United States