NCT00149292

Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo

A Randomized, Double-Blind Comparison of LY2140023, Olanzapine, and Placebo in the Treatment of Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Denovo Biopharma LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia. The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score.

Detailed description

The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score. The secondary objectives of the study were to assess the safety and tolerability of LY2140023 compared with placebo and olanzapine; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS total score; efficacy of LY2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS negative symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in mood and anxiety as measured by the Hamilton Anxiety Scale (HAMA) total score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the Clinical Global Impression-Severity (CGI-S); effect of LY2140023 on prolactin levels of the patients after 4 weeks of treatment; efficacy of olanzapine compared with placebo on the PANSS total score; pharmacokinetics of LY2140023 and LY404039 in patients, and to explore the relationship between exposure and efficacy.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	LY2140023
DRUG	olanzapine
DRUG	placebo

Timeline

• Start date: 2005-08-23
• Primary completion: 2006-07-17
• Completion: 2006-07-17
• First posted: 2005-09-08
• Last updated: 2021-08-20

Locations

2 sites across 1 country: Russia