A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denovo Biopharma LLC; Eli Lilly and Company
• Treatments: Olanzapine

Criteria

Inclusion Criteria:

• Clinical diagnosis of schizophrenia

• Participants must have been receiving monotherapy treatment for at least 3 months prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole, olanzapine, risperidone, quetiapine)

• Disease symptoms must meet a certain range as assessed by the clinician

• Participants must have evidence of prominent negative symptoms of schizophrenia (for example blunted affect, emotional withdrawal, or motor retardation)

• Participants must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures

• Participants must be able to understand the nature of the study and have given their informed consent

Exclusion Criteria:

• Participants who are actively suicidal

• Participants who are pregnant or nursing

• Participants who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study

• Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses

• Participants with Parkinson's disease, psychosis related to dementia or related disorders

• Participants with known Human Immunodeficiency Virus positive (HIV+) status