Overview

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