NCT01052103

A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

A 17-Week, Phase 2, Multicenter, Randomized, Double-Blind Study of Treatment With LY2140023 Combined With Standard of Care (SOC) Compared to Placebo With SOC in the Treatment of Patients With Prominent Negative Symptoms of Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (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 LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.

Detailed description

The primary objective of this study was to test the hypothesis that treatment with LY2140023 compared to placebo, when added to a fixed dose of a standard of care (SOC) antipsychotic, would demonstrate significantly greater reduction of negative symptoms, as assessed by the 16-item Negative Symptom Assessment scale (NSA-16), in patients with schizophrenia. Patients included in this study were concurrently receiving 1 of 4 second generation antipsychotics (SGAs): aripiprazole, olanzapine, risperidone, or quetiapine.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	LY2140023	40 milligrams (mg), oral tablets, twice daily: 20 mg in the morning, 20 mg in the evening, for 16 or 17 weeks. The dose may be adjusted to a minimum of 20 mg or a maximum of 80 mg.
DRUG	Placebo	Placebo oral tablets, twice daily: in the morning and in the evening, for 16 or 17 weeks.
DRUG	Standard of Care	United States (U.S.) label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine)

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-01-20
• Last updated: 2022-09-07
• Results posted: 2021-09-22

Locations

9 sites across 4 countries: United States, Israel, Italy, Spain