NCT01328093

A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients With DSM-IV-TR Schizophrenia Followed by Open-Label Treatment With LY2140023

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 678 (actual)
• Sponsor: Denovo Biopharma LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.

Detailed description

The primary objective of this study was to test the hypothesis that mean weight gain, as assessed by change from baseline, would be statistically significantly less for flexibly dosed LY2140023 (20, 40, or 80 mg twice daily \[BID\]) than for flexibly dosed aripiprazole (10, 15, or 30 mg/day) in patients with schizophrenia after 24 weeks of double-blind treatment. This was a multicenter, randomized, double-blind, Phase 3 study to assess the safety and efficacy of LY2140023 (flexibly dosed between 20 and 80 mg BID) in patients with schizophrenia. An active control, aripiprazole (flexibly dosed between 10 and 30 mg/day), was included for comparison.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	LY2140023	Administered orally
DRUG	Aripiprazole	Administered orally

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-04-04
• Last updated: 2022-09-07
• Results posted: 2022-09-07

Locations

51 sites across 10 countries: United States, Austria, Belgium, France, Germany, Poland, Puerto Rico, Romania, Spain, Sweden