NCT01909466

Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia

An Open-label, Multiple Dose, Safety and Tolerability Study of Aripiprazole IM Depot Administered in the Deltoid Muscle in Adult Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia

Detailed description

This is a trial designed to assess the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia. The trial consists of a 113 day treatment period with a 28 day followup. The trial population will include male and female subjects between 18 and 64 years (inclusive), with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a prior history of tolerating aripiprazole per investigator's judgement.

Conditions

• Schizophrenia
• Mental Disorder
• Nervous System Diseases

Interventions

Type	Name	Description
DRUG	Aripiprazole, OPC-14597	5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2013-07-26
• Last updated: 2015-07-01
• Results posted: 2015-06-02

Locations

11 sites across 1 country: United States