CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 167 enrolled
Drug / intervention
LY2140023 +2 moredrug
Likely dose
LY2140023 40 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01052103
NCT01052103Phase 2Completed
CompareCT.gov

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

Denovo Biopharma LLC·interventional·Posted Jan 20, 2010·Updated Sep 7, 2022

In Brief

A Phase 2 clinical trial evaluating LY2140023, Placebo, and 1 other intervention for Schizophrenia. Completed, enrolled 167 participants across 9 sites in 4 countries.

Detailed Summary

The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesIsrael, Italy, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2010
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.4 years ago

Interventions

LY2140023drug

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.

Placebodrug

Placebo oral tablets, twice daily: in the morning and in the evening, for 16 or 17 weeks.

Standard of Caredrug

United States (U.S.) label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine)