A Study of LY2140023 in Patients With Schizophrenia



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:March 2011
End Date:September 2012
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 Monohydrate in the Acute Treatment of Patients With DSM‑IV‑TR Schizophrenia


The purpose of this study is to determine whether at least 1 dose level of LY2140023 given
to acutely ill patients with schizophrenia will demonstrate significantly greater efficacy
as compared to placebo.


Inclusion Criteria:

- Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition, Text Revision DSM-IV-TR; and confirmed by the
Structured Clinical Interview for DSM-IV-TR (SCID)

- Non pregnant female patients who agree to use acceptable birth control

- Participants must be considered moderately ill in the opinion of the investigator

- Patients in whom a modification of antipsychotic medication or initiation of
antipsychotic medication is acutely indicated in the opinion of the investigator

- Willing to participate in a minimum of 2 weeks of inpatient hospitalization.

- One year history of Schizophrenia prior to entering the study

- At study entry patients with a history of antipsychotic treatment must have a
lifetime history of at least one hospitalization for the treatment of schizophrenia,
not including the hospitalization required for study. Patients who have never taken
antipsychotic treatment may enter the study even without a history of hospitalization

- At study entry patients with a history of antipsychotic treatment must have a history
of at least one episode of illness exacerbation requiring an intensification of
treatment intervention or care in the last 2 years, not including the present episode
of illness. Patients who have never taken antipsychotic treatment may enter the study
without a past history of illness exacerbation and intensification of treatment in
the last 2 years

- At study entry patients must have experienced an exacerbation of illness within the 2
weeks prior to entering the study, leading to an intensification of psychiatric care
in the opinion of the investigator. If exacerbation occurs in patients who are
presently hospitalized, the patient must not have been hospitalized longer than 60
days at entry of the study

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

Exclusion Criteria:

- Patients who have a history of inadequate clinical response to antipsychotic
treatment for schizophrenia

- Diagnosis of substance dependence or substance abuse within 6 month of study entry

- Diagnosis of substance-induced psychosis within 7 days of study entry

- Currently enrolled in, or discontinued within 6 months from a clinical trial
involving an investigational product or unapproved use of a drug or device

- Participated in any clinical trial with any pharmacological treatment intervention
for which they received a study-related medication in the 6 months prior to study
entry

- Previously completed or withdrawn from this study, or any other study investigating
LY2140023 or any predecessor molecules with glutamatergic activity

- Treatment with clozapine at doses greater than 200 mg daily within 12 months prior to
entering the study, or who have received any clozapine at all during the month before
study entry

- Patients currently receiving treatment (within 1 dosing interval, minimum of 4 weeks,
prior entering the study) with a depot formulation of an antipsychotic medication

- Patients who are currently suicidal

- Females who are pregnant, nursing, or who intend to become pregnant within 30 days of
completing the study

- Patients with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain
diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other
serious or unstable illnesses

- Have a history of one or more seizures

- Electroconvulsive therapy (ECT) within 3 months of entering the study or who will
have ECT at any time during the study

- History of low white blood cell count

- Medical history of Human Immunodeficiency Virus positive (HIV+) status.

- Higher than normal blood prolactin levels

- Abnormal electrocardiogram results
We found this trial at
14
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Philadelphia, Pennsylvania 19107
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Washington, District of Columbia 20010
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